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
NDC Product Code67046-029
Application NumberANDA202446
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 18, 2017
Generic NameAMITRIPTYLINE HYDROCHLORIDE
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
NDC Product Code67046-034
Application NumberANDA202446
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 18, 2017
Generic NameAMITRIPTYLINE HYDROCHLORIDE
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
NDC Product Code67046-035
Application NumberANDA202446
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 18, 2017
Generic NameAMITRIPTYLINE HYDROCHLORIDE
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