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Active ingredient

Pregabalin

542 finished FDA listings contain Pregabalin as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
PREGABALIN
Dosage forms
Capsule, Solution, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
56
Strengths listed
100 mg/1 · 150 mg/1 · 165 mg/1 · 20 mg/ml · 200 mg/1 · 225 mg/1 · 25 mg/1 · 300 mg/1 · 330 mg/1 · 50 mg/1 · 75 mg/1 · 82.5 mg/1
Brand names in FDA listings
Lyrica, Lyrica Cr, Pregabalin Extended Release

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 187832

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
NDA 021446UPJOHN2004-12-309
NDA 022488UPJOHN2010-01-042
NDA 209501UPJOHN2017-10-113
ANDA 209357MSN2019-07-1937
ANDA 209743AMNEAL PHARMS CO2019-07-1927
ANDA 208677SCIEGEN PHARMS2019-07-19134
ANDA 211384INVAGEN PHARMS2019-07-1924
ANDA 207623ALKEM LABS LTD2019-07-191
ANDA 203459ALEMBIC2019-07-1916
ANDA 209664DR REDDYS2019-07-198
ANDA 210432RISING2019-07-1948
ANDA 207799ALKEM LABS LTD2019-07-1937
ANDA 206912HETERO LABS LTD III2019-10-0840
ANDA 091157SUN PHARM2019-11-298
ANDA 212280CIPLA2020-01-108
ANDA 212865CHARTWELL RX2020-03-204
ANDA 213423CREEKWOOD PHARMS2020-03-238
ANDA 213226MSN2021-04-133
ANDA 214322CHANGZHOU PHARM2021-07-157
ANDA 212604ANDA REPOSITORY2022-02-181
ANDA 212988PHARMAZONE2022-03-0826
ANDA 215249RUBICON RESEARCH2022-03-223
ANDA 216197MARKSANS PHARMA2022-07-188
ANDA 207883PRINSTON INC2022-09-018
ANDA 215675SCIEGEN PHARMS2022-09-143
ANDA 205321AUROBINDO PHARMA2023-03-2920
ANDA 206452CADILA PHARMS LTD2023-07-128
ANDA 208113REGCON HOLDINGS2024-05-178
ANDA 205924MACLEODS PHARMS2024-11-128
ANDA 206942TORRENT2025-02-219
ANDA 218529CAPLIN2026-02-248
ANDA 219593UNICHEM2026-04-308

Official labeling on DailyMed

Showing the 12 most recent of 228 labels.

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