Active ingredient
Atropine
81 finished FDA listings contain Atropine as their only active ingredient; 66 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- ATROPINE, ATROPINE SULFATE
- Dosage forms
- Injection, Injection, Solution, Ointment, Solution, Solution/ Drops
- Routes
- Endotracheal, Intramedullary, Intramuscular, Intravascular, Intravenous, Ophthalmic, Subcutaneous
- Manufacturers / labelers
- 31
- Strengths listed
- .05 mg/ml · .1 mg/ml · .25 mg/.3ml · .4 mg/ml · .5 mg/.7ml · 1 mg/.7ml · 1 mg/ml · 10 mg/g · 10 mg/ml · 2 mg/.7ml
- Brand names in FDA listings
- Atropen Auto-Injector, Atropine, Atropine Sulfate, Isopto Atropine
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1223
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 017106 | MMT | 1973-05-15 | 5 |
| NDA 021146 | HOSPIRA | 2001-07-09 | 5 |
| NDA 208151 | ALCON LABS INC | 2016-12-01 | 2 |
| NDA 209260 | FRESENIUS KABI USA | 2018-01-26 | 4 |
| NDA 212319 | RAFA LABS LTD | 2018-07-09 | 1 |
| ANDA 212461 | INTL MEDICATION SYS | 2020-10-05 | 6 |
| ANDA 213424 | ACCORD HLTHCARE | 2021-03-19 | 1 |
| ANDA 212868 | ACCORD HLTHCARE | 2021-07-26 | 3 |
| ANDA 215624 | APOTEX | 2021-11-26 | 3 |
| ANDA 213561 | HIKMA | 2021-12-01 | 4 |
| ANDA 215342 | AMNEAL | 2022-01-26 | 3 |
| NDA 213581 | BAUSCH AND LOMB INC | 2022-03-15 | 2 |
| ANDA 216120 | AM REGENT | 2022-05-26 | 7 |
| ANDA 214752 | AMNEAL | 2022-07-14 | 4 |
| ANDA 214970 | MEDEFIL INC | 2022-11-04 | 2 |
| ANDA 218148 | MANKIND PHARMA | 2024-01-08 | 5 |
| ANDA 217791 | SOMERSET | 2024-04-29 | 1 |
| ANDA 215618 | SOMERSET THERAPS LLC | 2024-07-01 | 3 |
| ANDA 215969 | SOMERSET THERAPS LLC | 2024-07-03 | 5 |
| ANDA 215005 | SOMERSET THERAPS LLC | 2024-11-29 | 2 |
| ANDA 217345 | HIKMA | 2025-10-24 | 2 |
| ANDA 219013 | EDENBRIDGE PHARMS | 2026-04-15 | 1 |
| ANDA 219996 | GLAND | 2026-07-31 | 3 |
Official labeling on DailyMed
- ATROPINE SULFATE INJECTION [REMEDYREPACK INC.] · version 3 · 2026-09-07
- ATROPINE SULFATE INJECTION, SOLUTION [REMEDYREPACK INC.] · version 5 · 2026-09-02
- ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [GLAND PHARMA LIMITED] · version 4 · 2026-08-04
- ATROPINE SULFATE INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 2 · 2026-07-30
- ATROPINE SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 11 · 2026-06-22
- ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] · version 31 · 2026-05-20
- ATROPINE SULFATE SOLUTION/ DROPS [EDENBRIDGE PHARMACEUTICALS LLC.] · version 2 · 2026-05-11
- ATROPINE SULFATE INJECTION [REMEDYREPACK INC.] · version 6 · 2026-04-06
- ATROPINE SULFATE SOLUTION [ALCON LABORATORIES, INC.] · version 8 · 2026-03-16
- ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [APOTEX CORP.] · version 8 · 2026-03-12
- N/A (ATROPINE SULFATE INJECTION USP, 1 MG/0.7 ML) INJECTION N/A (ATROPINE SULFATE INJECTION USP, 0.5 MG/0.7 ML) INJECTION N/A (ATROPINE INJECTION, 2 MG) INJECTION [RAFA LABORATORIES, LTD.] · version 8 · 2026-02-19
- ATROPINE SULFATE INJECTION [A-S MEDICATION SOLUTIONS] · version 6 · 2026-02-19
Showing the 12 most recent of 61 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.