Active ingredient
Oxytocin
11 finished FDA listings contain Oxytocin as their only active ingredient; 16 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- OXYTOCIN, OXYTOCIN ACETATE
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intramuscular, Intravenous
- Manufacturers / labelers
- 5
- Strengths listed
- 10 [iu]/ml · 10 [usp'u]/ml
- Brand names in FDA listings
- Pitocin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7824
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 018248 | FRESENIUS KABI USA | 1980-07-09 | 5 |
| NDA 018261 | PH HEALTH | 1980-11-19 | 4 |
| ANDA 200219 | HIKMA FARMACEUTICA | 2013-02-13 | 2 |
Official labeling on DailyMed
- OXYTOCIN INJECTION, SOLUTION [REMEDYREPACK INC.] · version 3 · 2026-09-02
- PITOCIN (OXYTOCIN) INJECTION [PAR HEALTH USA, LLC] · version 15 · 2026-05-21
- PITOCIN (OXYTOCIN) INJECTION [PAR HEALTH USA, LLC] · version 16 · 2026-05-20
- PITOCIN (OXYTOCIN) INJECTION [PAR HEALTH USA, LLC] · version 15 · 2026-05-20
- OXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 7 · 2026-02-13
- PITOCIN (OXYTOCIN) INJECTION [PAR HEALTH USA, LLC] · version 10 · 2025-12-25
- OXYTOCIN INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC] · version 4 · 2025-06-30
- OXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 2 · 2025-04-09
- OXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 9 · 2024-11-27
- OXYTOCIN INJECTION [WEST-WARD PHARMACEUTICALS CORP] · version 2 · 2018-12-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.