Tramadol Hydrochloride (Page 8 of 8)

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TRAMADOL HYDROCHLORIDE tramadol hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-960(NDC:69467-1001)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMADOL HYDROCHLORIDE (TRAMADOL) TRAMADOL HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
TITANIUM DIOXIDE
SHELLAC
FERRIC OXIDE YELLOW
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
STARCH, CORN
MAGNESIUM STEARATE
SUCROSE STEARATE
HYPROMELLOSES
TALC
POLYSORBATE 80
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
Product Characteristics
Color WHITE (opaque white) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code G;322;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-960-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:53217-960-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022370 07/01/2015
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 03/2017 Aidarex Pharmaceuticals LLC

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