Active ingredient
Propranolol
217 finished FDA listings contain Propranolol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE
- Dosage forms
- Capsule, Extended Release, Injection, Injection, Solution, Solution, Tablet
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 46
- Strengths listed
- 1 mg/ml · 10 mg/1 · 120 mg/1 · 160 mg/1 · 20 mg/1 · 20 mg/5ml · 4.28 mg/ml · 40 mg/1 · 40 mg/5ml · 60 mg/1 · 80 mg/1
- Brand names in FDA listings
- Hemangeol, Inderal La, Inderal Xl, Innopran Xl, Propranolol, Propranolol Hydrochloride Er
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8787
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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018553 | ANI PHARMS | 1983-04-19 | 8 |
| ANDA 070213 | MYLAN | 1985-11-19 | 12 |
| ANDA 070221 | PH HEALTH | 1986-04-14 | 27 |
| ANDA 070177 | WATSON LABS | 1986-05-13 | 1 |
| ANDA 070322 | INNOGENIX | 1986-08-04 | 33 |
| ANDA 070690 | HIKMA | 1987-05-15 | 2 |
| ANDA 071976 | IMPAX LABS INC | 1988-04-06 | 3 |
| ANDA 071972 | IMPAX LABS INC | 1988-04-06 | 31 |
| ANDA 075826 | FRESENIUS KABI USA | 2001-08-31 | 5 |
| NDA 021438 | ANI PHARMS | 2003-03-12 | 4 |
| ANDA 078494 | ACTAVIS ELIZABETH | 2007-08-10 | 6 |
| ANDA 077760 | HIKMA FARMACEUTICA | 2008-01-31 | 3 |
| ANDA 078955 | IPCA LABS LTD | 2008-06-02 | 25 |
| ANDA 078703 | ADARE PHARMS INC | 2011-07-15 | 30 |
| NDA 205410 | ETON | 2014-03-14 | 2 |
| ANDA 212026 | AMTA | 2020-01-06 | 9 |
| ANDA 216663 | MANKIND PHARMA | 2026-01-27 | 5 |
| ANDA 219165 | PAI HOLDINGS | 2026-06-10 | 2 |
| ANDA 219460 | CREEKWOOD PHARMS | 2026-08-14 | 4 |
Official labeling on DailyMed
- PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 1 · 2026-09-10
- PROPRANOLOL HYDROCHLORIDE TABLET [PAR HEALTH USA, LLC] · version 19 · 2026-09-10
- PROPRANOLOL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-07
- PROPRANOLOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] · version 5 · 2026-09-03
- PROPRANOLOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] · version 4 · 2026-09-03
- INNOPRAN XL (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] · version 8 · 2026-08-31
- PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CREEKWOOD PHARMACEUTICALS LLC] · version 1 · 2026-08-31
- PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] · version 10 · 2026-08-31
- INDERAL XL (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] · version 9 · 2026-08-31
- INDERAL LA (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] · version 11 · 2026-08-31
- PROPRANOLOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 7 · 2026-08-26
- PROPRANOLOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-08-26
Showing the 12 most recent of 140 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.