AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline Hydrochloride Tablets, USP
Approved
Approval ID
81c4f52a-f014-411c-a92b-3acf7ed61f31
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
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 Code63187-359
Application NumberANDA202446
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 1, 2022
Generic NameAMITRIPTYLINE HYDROCHLORIDE
INGREDIENTS (12)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 26LUD4JO9K
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT