Efavirenz (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Efavirenz Tablets 600 mg container Label 30s count

Efavirenztabcontlabel30s
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Efavirenz Tablets 600 mg container Label 250s count
Efavirenztabcontlabel250s
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EFAVIRENZ efavirenz tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-504
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EFAVIRENZ (EFAVIRENZ) EFAVIRENZ 600 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE (Capsular) Size 21mm
Flavor Imprint Code H;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-504-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:31722-504-25 250 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078886 04/27/2018
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit III 676162024 ANALYSIS (31722-504), RELABEL (31722-504), MANUFACTURE (31722-504)

Revised: 11/2019 Camber Pharmaceuticals, Inc.

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