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NDC 63629-8319-02 TRAMADOL HYDROCHLORIDE 200 mg/1 Details

TRAMADOL HYDROCHLORIDE 200 mg/1

TRAMADOL HYDROCHLORIDE is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 63629-8319-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tramadol

Product Information

NDC	63629-8319
Product ID	63629-8319_34b199b9-6db9-4f7b-8aca-677cbe0fa528
Associated GPIs	65100095107530
GCN Sequence Number	043536
GCN Sequence Number Description	tramadol HCl TAB ER 24H 200 MG ORAL
HIC3	H3A
HIC3 Description	OPIOID ANALGESICS
GCN	50417
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	200
Active Ingredient Units	mg/1
Substance Name	TRAMADOL HYDROCHLORIDE
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA Schedule	CIV
Marketing Category	ANDA
Application Number	ANDA200503
Listing Certified Through	2024-12-31

Package

NDC 63629-8319-02 (63629831902)

Pricing Information	N/A
NDC Package Code	63629-8319-2
Billing NDC	63629831902
Package	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8319-2)
Marketing Start Date	2020-05-14
NDC Exclude Flag	N