AMITRIPTYLINE HYDROCHLORIDE
Approved
Approval ID
abfb3e0e-7243-433b-9c8c-4f39e625c9ad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-437
Application NumberANDA086009
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMITRIPTYLINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2010
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 26LUD4JO9K
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT