Active ingredient
Penicillamine
12 finished FDA listings contain Penicillamine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PENICILLAMINE
- Dosage forms
- Capsule, Capsule, Gelatin Coated, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 11
- Strengths listed
- 250 mg/1
- Brand names in FDA listings
- Aagylur, Cuprimine, Depen
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7975
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 019853 | VALEANT PHARMS INTL | 1970-12-04 | 1 |
| NDA 019854 | MYLAN SPECIALITY LP | 1978-11-08 | 1 |
| ANDA 210976 | WATSON LABS INC | 2019-06-24 | 1 |
| ANDA 211196 | PH HEALTH | 2019-12-23 | 1 |
| ANDA 211231 | PH HEALTH | 2019-12-23 | 1 |
| ANDA 211867 | DR REDDYS | 2020-08-04 | 1 |
| ANDA 212933 | LUPIN | 2020-11-30 | 1 |
| ANDA 211735 | GRANULES | 2020-12-02 | 2 |
| ANDA 213293 | INVAGEN PHARMS | 2021-08-19 | 1 |
| ANDA 215409 | BRECKENRIDGE | 2021-08-23 | 1 |
| ANDA 214363 | NAVINTA LLC | 2021-10-08 | 1 |
Official labeling on DailyMed
- PENICILLAMINE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.] · version 3 · 2026-08-24
- PENICILLAMINE CAPSULE [PAR HEALTH USA, LLC] · version 7 · 2026-08-07
- PENICILLAMINE TABLET, FILM COATED [PAR HEALTH USA, LLC] · version 11 · 2026-08-07
- CUPRIMINE (PENICILLAMINE) CAPSULE [BAUSCH HEALTH US, LLC] · version 17 · 2026-01-28
- DEPEN (PENICILLAMINE) TABLET [VIATRIS SPECIALTY LLC] · version 8 · 2025-12-08
- AAGYLUR (PENICILLAMINE) CAPSULE [CYCLE PHARMACEUTICALS LTD.] · version 1 · 2025-09-29
- PENICILLAMINE CAPSULE [ACTAVIS PHARMA, INC.] · version 4 · 2025-08-15
- PENICILLAMINE CAPSULE [GRANULES PHARMACEUTICALS INC.] · version 3 · 2025-05-08
- PENICILLAMINE TABLET [LUPIN PHARMACEUTICALS, INC.] · version 6 · 2023-01-05
- PENICILLAMINE CAPSULE [NAVINTA LLC] · version 2 · 2022-12-13
- PENICILLAMINE CAPSULE [PROFICIENT RX LP] · version 2 · 2022-04-20
- PENICILLAMINE CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES INC.] · version 3 · 2021-12-03
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.