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FDA Approval

Tramadol Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
REMEDYREPACK INC.
DUNS: 829572556
Effective Date
December 5, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tramadol(50 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tramadol Hydrochloride

Product Details

NDC Product Code
24236-609
Application Number
ANDA076003
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 5, 2011
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
TramadolActive
Code: 9N7R477WCKClass: ACTIBQuantity: 50 mg in 1 1
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2Class: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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