Label: TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69512-627-10 - Packager: Alivio Medical Products, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 16, 2015
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- DESCRIPTION
- DESCRIPTION
- STORAGE AND HANDLING
- DESCRIPTION
- CLINICAL PHARMACOLOGY
- CLINICAL STUDIES
- INDICATIONS & USAGE
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69512-627 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE 50 mg in 50 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white (White) Score no score Shape ROUND Size 9mm Flavor Imprint Code AN;627 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69512-627-10 100 in 1 BOTTLE 1 50 mg in 1 CAPSULE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076003 10/01/2015 Labeler - Alivio Medical Products, LLC (079670828)