Carisoprodol (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69584-111-10
Carisoprodol
TABLETS, USP
350 mg CIV
Rx only
100 TABLETS

EACH TABLET CONTAINS:
Carisoprodol, USP…………350 mg
USUAL DOSAGE: See package insert for full prescribing information.
DISPENSE in a tight, light-resistant container as defined in the USP, using a child-resistant closure.
STORE at 20° to 24°C (68° to 77°F) [see USP Controlled Room Temperature]
Keep container tightly closed.
KEEP THIS AND ALL MEDICATOINS OUT OF REACH OF CHILDREN
Manufactured by:
OXFORD PHARMACEUTICALS
BIRMINGHAM, ALABAMA 35211
8000041 REV: 00
OXFORD
PHARMACEUTICALS, LLC

Label
(click image for full-size original)
CARISOPRODOL carisoprodol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69584-111
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARISOPRODOL (CARISOPRODOL) CARISOPRODOL 350 mg
Inactive Ingredients
Ingredient Name Strength
Hypromellose 2910 (50 Mpa.S)
Lactose Monohydrate
Microcrystalline Cellulose 101
Sodium Starch Glycolate Type A Potato
Stearic Acid
Talc
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 111;O
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69584-111-10 100 TABLET in 1 BOTTLE None
2 NDC:69584-111-50 500 TABLET in 1 BOTTLE None
3 NDC:69584-111-90 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040188 01/20/2020
Labeler — Oxford Pharmaceuticals, LLC (079638266)
Establishment
Name Address ID/FEI Operations
Oxford Pharmaceuticals, LLC 079638266 manufacture (69584-111)

Revised: 09/2019 Oxford Pharmaceuticals, LLC

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