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Active ingredient

Ephedrine

43 finished FDA listings contain Ephedrine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
EPHEDRINE, EPHEDRINE HYDROCHLORIDE, EPHEDRINE SULFATE
Dosage forms
Injection, Injection, Solution, Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Intravenous, Oral
Manufacturers / labelers
28
Strengths listed
12.5 mg/1 · 25 mg/1 · 5 mg/ml · 50 mg/ml
Brand names in FDA listings
Akovaz, Bronkaid Max, Emerphed, Emerphed Pfs, Primatene

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3966

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 208289EXELA PHARMA2016-04-292
NDA 208943PH HEALTH2017-01-273
ANDA 209784SANDOZ2017-08-232
ANDA 212932AMNEAL2019-10-234
NDA 213407NEXUS2020-04-173
ANDA 209646FRESENIUS KABI USA2020-08-041
ANDA 212649DR REDDYS2020-10-031
NDA 213994PH HEALTH2020-10-162
ANDA 214334HIKMA2020-12-151
ANDA 214579EUGIA PHARMA2021-06-143
ANDA 216146GLAND2022-02-253
ANDA 216129MANKIND PHARMA2022-04-144
ANDA 215825XIROMED2022-04-212
ANDA 214528SAGENT PHARMS INC2023-03-091
ANDA 219050CAPLIN2024-07-181
ANDA 217721HIKMA2024-10-111
ANDA 218211GLAND2025-01-161
ANDA 218271FRESENIUS KABI USA2025-03-112
ANDA 216740BAXTER HLTHCARE CORP2026-07-081

Official labeling on DailyMed

Showing the 12 most recent of 38 labels.

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