TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tramadol Hydrochloride Tablets USP, 50 mg

NDC 65841-754-01 in bottle of 100 tablets

100 tablets

Rx only

Tramadol HCl Tablets
(click image for full-size original)
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-754
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMADOL HYDROCHLORIDE (TRAMADOL) TRAMADOL HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code 319
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-754-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-754-30)
2 NDC:65841-754-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-754-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-754-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090404 01/31/2011
Labeler — Cadila Healthcare Limited (918596198)
Registrant — CADILA HEALTHCARE LIMITED (677605858)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-754), MANUFACTURE (65841-754)
Establishment
Name Address ID/FEI Operations
CADILA HEALTHCARE LIMITED 677605858 ANALYSIS (65841-754), MANUFACTURE (65841-754)

Revised: 09/2020 Cadila Healthcare Limited

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