Amitriptyline Hydrochloride
Amitriptyline Hydrochloride Tablets, USP Rx Only
Approved
Approval ID
fd771b4b-c7ae-8e69-e053-6294a90a2120
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 6, 2023
Manufacturers
FDA
AvPAK
DUNS: 832926666
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amitriptyline Hydrochloride
PRODUCT DETAILS
NDC Product Code50268-037
Application NumberANDA214548
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 6, 2023
Generic NameAmitriptyline Hydrochloride
INGREDIENTS (12)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 26LUD4JO9K
Classification: ACTIB
Amitriptyline Hydrochloride
PRODUCT DETAILS
NDC Product Code50268-038
Application NumberANDA214548
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 6, 2023
Generic NameAmitriptyline Hydrochloride
INGREDIENTS (10)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 26LUD4JO9K
Classification: ACTIB
Amitriptyline Hydrochloride
PRODUCT DETAILS
NDC Product Code50268-039
Application NumberANDA214548
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 6, 2023
Generic NameAmitriptyline Hydrochloride
INGREDIENTS (12)
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 26LUD4JO9K
Classification: ACTIB
Amitriptyline Hydrochloride
PRODUCT DETAILS
NDC Product Code50268-040
Application NumberANDA214548
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 6, 2023
Generic NameAmitriptyline Hydrochloride
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 26LUD4JO9K
Classification: ACTIB