tramadol hydrochloride (50090-5789)

Drug Facts

Product Profile

Brand Name tramadol hydrochloride

Generic Name tramadol hydrochloride

Labeler a-s medication solutions

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5789

Product ID 50090-5789_d2130333-f392-4f3c-b988-c4147c6c9595

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211825

DEA Schedule civ

Listing Expiration 2027-12-31

Marketing Start 2019-08-09

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500905789

Hyphenated Format 50090-5789

Supplemental Identifiers

RxCUI

835603

UNII

9N7R477WCK

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tramadol hydrochloride (source: ndc)

Generic Name tramadol hydrochloride (source: ndc)

Application Number ANDA211825 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

50 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (50090-5789-0)
20 TABLET, FILM COATED in 1 BOTTLE (50090-5789-1)
50 TABLET, FILM COATED in 1 BOTTLE (50090-5789-2)
15 TABLET, FILM COATED in 1 BOTTLE (50090-5789-4)
60 TABLET, FILM COATED in 1 BOTTLE (50090-5789-5)
120 TABLET, FILM COATED in 1 BOTTLE (50090-5789-9)

source: ndc

Packages (6)

50090-5789-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-5789-0) 50090-5789-1 20 TABLET, FILM COATED in 1 BOTTLE (50090-5789-1) 50090-5789-2 50 TABLET, FILM COATED in 1 BOTTLE (50090-5789-2) 50090-5789-4 15 TABLET, FILM COATED in 1 BOTTLE (50090-5789-4) 50090-5789-5 60 TABLET, FILM COATED in 1 BOTTLE (50090-5789-5) 50090-5789-9 120 TABLET, FILM COATED in 1 BOTTLE (50090-5789-9)

Ingredients (1)

tramadol hydrochloride (50 mg/1)

Linked Drug Pages (1)

Tramadol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

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