Active ingredient
Dicyclomine
130 finished FDA listings contain Dicyclomine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DICYCLOMINE HYDROCHLORIDE
- Dosage forms
- Capsule, Injection, Injection, Solution, Solution, Tablet
- Routes
- Intramuscular, Oral
- Manufacturers / labelers
- 43
- Strengths listed
- 10 mg/1 · 10 mg/5ml · 10 mg/ml · 20 mg/1 · 20 mg/2ml · 40 mg/1
- Brand names in FDA listings
- Dicyclomine
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3361
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 |
|---|---|---|---|
| ANDA 084285 | LANNETT | 1974-09-30 | 12 |
| ANDA 085082 | WATSON LABS | 1976-07-28 | 10 |
| ANDA 085223 | WATSON LABS | 1976-08-17 | 5 |
| ANDA 040161 | HIKMA PHARMS | 1996-10-01 | 3 |
| ANDA 040204 | WEST WARD | 1997-02-28 | 4 |
| ANDA 040230 | LANNETT | 1999-02-26 | 13 |
| ANDA 040317 | AUROBINDO PHARMA USA | 1999-09-07 | 10 |
| ANDA 040319 | AUROBINDO PHARMA USA | 1999-09-07 | 7 |
| ANDA 040465 | HIKMA | 2003-06-30 | 1 |
| ANDA 040169 | PH HEALTH | 2005-03-24 | 1 |
| ANDA 208353 | AM REGENT | 2017-02-17 | 1 |
| ANDA 210979 | FOSUN PHARMA | 2018-07-02 | 1 |
| ANDA 207076 | SLATE RUN PHARMA | 2018-11-02 | 1 |
| ANDA 210257 | FRESENIUS KABI USA | 2019-01-25 | 2 |
| ANDA 212286 | HIKMA | 2020-05-22 | 1 |
| ANDA 214721 | NOVITIUM PHARMA | 2021-04-23 | 2 |
| ANDA 216760 | COREPHARMA | 2022-11-28 | 3 |
| ANDA 216736 | RUBICON RESEARCH | 2022-12-14 | 11 |
| ANDA 217054 | TWI PHARMS | 2022-12-27 | 7 |
| ANDA 216639 | COREPHARMA | 2023-03-24 | 4 |
| ANDA 216782 | TWI PHARMS | 2023-06-01 | 8 |
| ANDA 217916 | BIONPHARMA | 2023-08-04 | 5 |
| ANDA 217531 | PRINSTON INC | 2023-08-30 | 3 |
| ANDA 217566 | ANNORA PHARMA | 2024-05-07 | 7 |
| ANDA 218018 | ANNORA PHARMA | 2024-07-01 | 2 |
| ANDA 214332 | SOMERSET THERAPS LLC | 2024-11-01 | 1 |
| ANDA 214333 | SOMERSET THERAPS LLC | 2024-11-01 | 1 |
| ANDA 218952 | RISING | 2024-11-15 | 2 |
| ANDA 219242 | RISING | 2025-06-23 | 1 |
| ANDA 216515 | RUBICON RESEARCH | 2026-07-17 | 1 |
Official labeling on DailyMed
- DICYCLOMINE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.] · version 2 · 2026-09-11
- DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE) TABLET [REMEDYREPACK INC.] · version 2 · 2026-09-10
- DICYCLOMINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 4 · 2026-09-07
- DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] · version 8 · 2026-09-02
- DICYCLOMINE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH 107, LLC] · version 7 · 2026-08-25
- DICYCLOMINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 14 · 2026-08-24
- DICYCLOMINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 10 · 2026-08-20
- DICYCLOMINE HYDROCHLORIDE TABLET [REDPHARM DRUG] · version 1 · 2026-08-19
- DICYCLOMINE HYDROCHLORIDE CAPSULE [REDPHARM DRUG] · version 1 · 2026-08-17
- DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, LLC] · version 25 · 2026-08-14
- DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 3 · 2026-08-14
- DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-08-14
Showing the 12 most recent of 118 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.