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NDC 68382-0319-77 TRAMADOL HYDROCHLORIDE 50 mg/1 Details

TRAMADOL HYDROCHLORIDE 50 mg/1

TRAMADOL HYDROCHLORIDE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is TRAMADOL HYDROCHLORIDE.

MedlinePlus Drug Summary

Tramadol is used to relieve moderate to moderately severe pain. Tramadol extended-release tablets and capsules are only used by people who are expected to need medication to relieve pain around-the-clock. Tramadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Related Packages: 68382-0319-77
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tramadol

Product Information

NDC	68382-0319
Product ID	68382-319_bb1192b5-c05a-487b-aae7-c226512dd45b
Associated GPIs	65100095100320
GCN Sequence Number	023139
GCN Sequence Number Description	tramadol HCl TABLET 50 MG ORAL
HIC3	H3A
HIC3 Description	OPIOID ANALGESICS
GCN	07221
HICL Sequence Number	008317
HICL Sequence Number Description	TRAMADOL HCL
Brand/Generic	Generic
Proprietary Name	TRAMADOL HYDROCHLORIDE
Proprietary Name Suffix	n/a
Non-Proprietary Name	TRAMADOL HYDROCHLORIDE
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	TRAMADOL HYDROCHLORIDE
Labeler Name	Zydus Pharmaceuticals USA Inc.
Pharmaceutical Class	Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA Schedule	CIV
Marketing Category	ANDA
Application Number	ANDA090404
Listing Certified Through	2024-12-31

Package

NDC 68382-0319-77 (68382031977)

Pricing Information	N/A
NDC Package Code	68382-319-77
Billing NDC	68382031977
Package	100 BLISTER PACK in 1 CARTON (68382-319-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-319-30)
Marketing Start Date	2011-01-31
NDC Exclude Flag	N