AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride Tablets, USP 029 034 035
Approved
Approval ID
59774c8a-de96-53a6-e053-2991aa0a709f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2017
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
Products 3
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 Code67046-029
Application NumberANDA202446
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMITRIPTYLINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2017
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 26LUD4JO9K
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-034
Application NumberANDA202446
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMITRIPTYLINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2017
FDA Product Classification
INGREDIENTS (12)
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 26LUD4JO9K
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-035
Application NumberANDA202446
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMITRIPTYLINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2017
FDA Product Classification
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 26LUD4JO9K
Classification: ACTIB
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT