AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE
Approved
Approval ID
5e0f1cb3-5c78-4848-9a35-7ea20cc8ad7d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2015
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
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 Code61919-011
Application NumberANDA040218
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMITRIPTYLINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2015
FDA Product Classification
INGREDIENTS (11)
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
AMITRIPTYLINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 26LUD4JO9K
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT