Hydrocodone Bitartrate and Acetaminophen (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg/325 mg (100 Tablet Bottle)

NDC 13107-019-01
Hydrocodone Bitartrate and
Acetaminophen Tablets, USP CII
5 mg/325 mg
Rx only 100 Tablets AUROBINDO

hbtapap5mg100ct
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hbtapap5mg100ct

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 7.5 mg/325 mg (100 Tablet Bottle)

NDC 13107-020-01
Hydrocodone Bitartrate and
Acetaminophen Tablets, USP CII
7.5 mg/325 mg
Rx only 100 Tablets AUROBINDO

hbtapap7.5mg100ct
(click image for full-size original)

hbtapap7.5mg100ct

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg/325 mg (100 Tablet Bottle)

NDC 13107-021-01
Hydrocodone Bitartrate and
Acetaminophen Tablets, USP CII
10 mg/325 mg
Rx only 100 Tablets AUROBINDO

hbtapap10mg100ct
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EPM LABEL
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HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1791(NDC:13107-019)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white (White to Off-white) Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code U01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-1791-2 20 TABLET in 1 BOTTLE None
2 NDC:67296-1791-3 30 TABLET in 1 BOTTLE None
3 NDC:67296-1791-6 6 TABLET in 1 BOTTLE None
4 NDC:67296-1791-7 15 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201013 04/11/2012
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
EPM Packaging 079124340 repack (67296-1791), label (67296-1791)

Revised: 05/2020 RedPharm Drug, Inc.

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