ULTRAM- tramadol hcl tablet, coated

Ultram by

Drug Labeling and Warnings

Ultram by is a Prescription medication manufactured, distributed, or labeled by NORTHWIND PHARMACEUTICALS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NDC: 51655-0185-20

MFG: 65162-627-11

traMADOL HCL 50 MG

20 TABLETS  RX ONLY

DOSAGE: SEE PACKAGE INSERT

STORE AT 68 TO 77 DEGREES F

STORE IN A TIGHT, LIGHT-RESISTANT CONTAINER. (SEE USP) KEEP OUT OF REACH OF CHILDREN

EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE USP 50 MG

MFG BY: AMNEAL PHARMACEUTICALS PVT LTD AHMEDABAD INDIA 382220

REPACKAGED BY NORTHWIND PHARMACEUTICALS INDIANAPOLIS, IN 46256

LOT# NW76700002

EXP DATE: 09/2016

WARNINGS AND PRECAUTIONS

INGREDIENTS AND APPEARANCE

ULTRAM 
tramadol hcl tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51655-185(NDC:65162-627)
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 20

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	AN627
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51655-185-20	20 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076003	02/13/2014

Labeler - NORTHWIND PHARMACEUTICALS (036986393)

Registrant - NORTHWIND PHARMACEUTICALS (036986393)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHWIND PHARMACEUTICALS		036986393	repack(51655-185)