emtricitabine
These highlights do not include all the information needed to use EMTRICITABINE CAPSULES safely and effectively. See full prescribing information for EMTRICITABINE CAPSULES. EMTRICITABINE capsules, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
a229c922-58eb-4795-9219-6cebb1779e35
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
emtricitabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-642
Application NumberANDA091168
Product Classification
M
Marketing Category
C73584
G
Generic Name
emtricitabine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 25, 2023
FDA Product Classification
INGREDIENTS (9)
EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT