Amitriptyline Hydrochloride

Amitriptyline Hydrochloride Tablets, USPRx only

Approved

Approval ID

09c46ee2-6efc-4de3-a377-7bfeb9dba204

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 26, 2023

Manufacturers

FDA

Graviti Pharmaceuticals Private Limited

DUNS: 650884781

Products 6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Amitriptyline Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69844-060

Application NumberANDA217411

Product Classification

Marketing Category

C73584

Generic Name

Amitriptyline Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMay 26, 2023

FDA Product Classification

INGREDIENTS (16)

AMITRIPTYLINE HYDROCHLORIDEActive

Quantity: 50 mg in 1 1

Code: 26LUD4JO9K

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSE 101Inactive

Code: 7T9FYH5QMK

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

Amitriptyline Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69844-063

Application NumberANDA217411

Product Classification

Marketing Category

C73584

Generic Name

Amitriptyline Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMay 26, 2023

FDA Product Classification

INGREDIENTS (17)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

AMITRIPTYLINE HYDROCHLORIDEActive

Quantity: 150 mg in 1 1

Code: 26LUD4JO9K

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSE 101Inactive

Code: 7T9FYH5QMK

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

Amitriptyline Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69844-062

Application NumberANDA217411

Product Classification

Marketing Category

C73584

Generic Name

Amitriptyline Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMay 26, 2023

FDA Product Classification

INGREDIENTS (15)

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSE 101Inactive

Code: 7T9FYH5QMK

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

AMITRIPTYLINE HYDROCHLORIDEActive

Quantity: 100 mg in 1 1

Code: 26LUD4JO9K

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

Amitriptyline Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69844-059

Application NumberANDA217411

Product Classification

Marketing Category

C73584

Generic Name

Amitriptyline Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMay 26, 2023

FDA Product Classification

INGREDIENTS (16)

AMITRIPTYLINE HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: 26LUD4JO9K

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

MICROCRYSTALLINE CELLULOSE 101Inactive

Code: 7T9FYH5QMK

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Amitriptyline Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69844-058

Application NumberANDA217411

Product Classification

Marketing Category

C73584

Generic Name

Amitriptyline Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMay 26, 2023

FDA Product Classification

INGREDIENTS (16)

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CARMINIC ACIDInactive

Code: CID8Z8N95N

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

AMITRIPTYLINE HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: 26LUD4JO9K

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSE 101Inactive

Code: 7T9FYH5QMK

Classification: IACT

Amitriptyline Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69844-061

Application NumberANDA217411

Product Classification

Marketing Category

C73584

Generic Name

Amitriptyline Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMay 26, 2023

FDA Product Classification

INGREDIENTS (16)

AMITRIPTYLINE HYDROCHLORIDEActive

Quantity: 75 mg in 1 1

Code: 26LUD4JO9K

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSE 101Inactive

Code: 7T9FYH5QMK

Classification: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693Y

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CARMINIC ACIDInactive

Code: CID8Z8N95N

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

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Amitriptyline Hydrochloride

Products 6

Amitriptyline Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Amitriptyline Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Amitriptyline Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Amitriptyline Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Amitriptyline Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Amitriptyline Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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