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Active ingredient

Tramadol

128 finished FDA listings contain Tramadol as their only active ingredient; 16 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
TRAMADOL HYDROCHLORIDE
Dosage forms
Capsule, Capsule, Extended Release, Solution, Tablet, Tablet, Coated, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
43
Strengths listed
100 mg/1 · 200 mg/1 · 25 mg/1 · 300 mg/1 · 5 mg/ml · 50 mg/1 · 75 mg/1
Brand names in FDA listings
Conzip, Tramadol Hcl Er, Tramadol Hydrochloride Extended-Release

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 10689

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 075977TEVA2002-06-194
ANDA 076003AMNEAL PHARMS2002-06-2012
ANDA 075968GRAVITI PHARMS2002-06-256
NDA 022370CIPHER PHARMS INC2010-05-076
ANDA 200503LUPIN LTD2011-08-2933
ANDA 202075STRIDES PHARMA2011-11-2810
ANDA 201384SUN PHARM2011-12-0714
ANDA 091607SUN PHARM2011-12-304
ANDA 091498CSPC OUYI PHARM CO2013-03-291
ANDA 203494AUROBINDO PHARMA LTD2014-03-314
ANDA 208708RUBICON RESEARCH2019-06-2822
ANDA 211825UNICHEM2019-08-097
NDA 214044ROSEMOUNT2020-09-011
ANDA 209404MACLEODS PHARMS2025-01-314

Official labeling on DailyMed

Showing the 12 most recent of 98 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.