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NDC 47335-0537-83 TRAMADOL HYDROCHLORIDE 300 mg/1 Details

TRAMADOL HYDROCHLORIDE 300 mg/1

TRAMADOL HYDROCHLORIDE is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, 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: 47335-0537-83
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tramadol

Product Information

NDC	47335-0537
Product ID	47335-537_2122faf1-b357-4a4d-b732-60ddb96a507d
Associated GPIs	65100095107580
GCN Sequence Number	063424
GCN Sequence Number Description	tramadol HCl TBMP 24HR 300 MG ORAL
HIC3	H3A
HIC3 Description	OPIOID ANALGESICS
GCN	99153
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, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	300
Active Ingredient Units	mg/1
Substance Name	TRAMADOL HYDROCHLORIDE
Labeler Name	Sun Pharmaceutical Industries, Inc.
Pharmaceutical Class	Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA Schedule	CIV
Marketing Category	ANDA
Application Number	ANDA091607
Listing Certified Through	2024-12-31

Package

NDC 47335-0537-83 (47335053783)

Pricing Information	N/A
NDC Package Code	47335-537-83
Billing NDC	47335053783
Package	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-537-83)
Marketing Start Date	2011-12-30
NDC Exclude Flag	N