Active ingredient
Neostigmine
52 finished FDA listings contain Neostigmine as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- NEOSTIGMINE METHYLSULFATE
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 23
- Strengths listed
- .5 mg/ml · .51 mg/ml · 1 mg/ml · 1.02 mg/ml
- Brand names in FDA listings
- Bloxiverz
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7315
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 204078 | EXELA PHARMA | 2013-05-31 | 1 |
| NDA 203629 | FRESENIUS KABI USA | 2015-01-08 | 7 |
| ANDA 207042 | HIKMA | 2015-12-28 | 6 |
| ANDA 208405 | PH HEALTH | 2017-04-26 | 4 |
| ANDA 209933 | AMPHASTAR PHARMS INC | 2017-09-25 | 4 |
| ANDA 210051 | AMNEAL | 2018-06-15 | 2 |
| ANDA 209135 | DR REDDYS | 2018-07-10 | 3 |
| ANDA 212512 | BE PHARMS | 2019-05-13 | 4 |
| ANDA 212968 | GLAND | 2019-10-16 | 5 |
| ANDA 212804 | MEITHEAL | 2021-04-05 | 2 |
| ANDA 213074 | CAPLIN | 2021-04-20 | 7 |
| ANDA 210652 | REGCON HOLDINGS | 2021-10-01 | 2 |
| ANDA 216291 | DR REDDYS | 2022-07-06 | 1 |
| ANDA 208230 | AVET LIFESCIENCES | 2022-11-25 | 2 |
| ANDA 213244 | EUGIA PHARMA | 2023-11-02 | 2 |
Official labeling on DailyMed
- NEOSTIGMINE METHYLSULFATE INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 9 · 2026-06-22
- NEOSTIGMINE METHYLSULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 12 · 2026-03-20
- NEOSTIGMINE METHYLSULFATE INJECTION [PAR HEALTH USA, LLC] · version 10 · 2025-12-25
- NEOSTIGMINE METHYLSULFATE INJECTION [PROPHARMA DISTRIBUTION] · version 3 · 2025-07-21
- NEOSTIGMINE METHYLSULFATE INJECTION [INDOCO REMEDIES LIMITED ] · version 4 · 2025-03-21
- NEOSTIGMINE METHYLSULFATE INJECTION [XIROMED LLC] · version 6 · 2025-01-13
- NEOSTIGMINE METHYLSULFATE INJECTION [CIVICA, INC.] · version 5 · 2024-12-30
- NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 3 · 2024-10-21
- NEOSTIGMINE METHYLSULFATE INJECTION [EUGIA US LLC] · version 2 · 2024-09-11
- NEOSTIGMINE METHYLSULFATE INJECTION [AMNEAL PHARMACEUTICALS LLC] · version 8 · 2024-09-02
- NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [DR.REDDYS LABORATORIES INC] · version 4 · 2024-07-01
- NEOSTIGMINE METHYLSULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 2 · 2024-04-11
Showing the 12 most recent of 30 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.