NDC Code(s) : 24236-292-22
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Atriplaefavirenz, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24236-292
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EFAVIRENZ(UNII: JE6H2O27P8)
(EFAVIRENZ - UNII:JE6H2O27P8) 		EFAVIRENZ600 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL(UNII: 532B59J990)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color pink Score no score
Shape OVAL Size 20 mm
Flavor Imprint Code 123
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24236-292-22150 in 1 CANISTER Type 0: Not a Combination Product29/03/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021937 03/29/2013 03/29/2014

PRINCIPAL DISPLAY PANEL

DRUG: Atripla

GENERIC: efavirenz, emtricitabine, and tenofovir disoproxil fumarate

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 24236-292-22

COLOR: pink

SHAPE: OVAL

SCORE: No score

SIZE: 20 mm

IMPRINT: 123

PACKAGING: 150 in 1 CANISTER

ACTIVE INGREDIENT(S):

  • EFAVIRENZ 600mg in 1
  • EMTRICITABINE 200mg in 1
  • TENOFOVIR DISOPROXIL FUMARATE 300mg in 1

INACTIVE INGREDIENT(S):

  • CROSCARMELLOSE SODIUM
  • POLYVINYL ALCOHOL
  • FERRIC OXIDE RED
  • POLYETHYLENE GLYCOL 3350
  • TALC
  • FERROSOFERRIC OXIDE
  • HYDROXYPROPYL CELLULOSE (TYPE H)
  • MAGNESIUM STEARATE
  • SODIUM LAURYL SULFATE
  • CELLULOSE, MICROCRYSTALLINE
  • TITANIUM DIOXIDE

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