Active ingredient
Penicillin V
72 finished FDA listings contain Penicillin V as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PENICILLIN V POTASSIUM
- Dosage forms
- Powder, For Solution, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 17
- Strengths listed
- 125 mg/5ml · 250 mg/1 · 250 mg/5ml · 500 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7984
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 060711 | CHARTWELL RX | 1968-07-03 | 6 |
| ANDA 060456 | CHARTWELL RX | 1968-07-31 | 9 |
| ANDA 065435 | AUROBINDO PHARMA | 2008-04-29 | 42 |
| ANDA 090549 | HIKMA PHARMS | 2013-10-11 | 15 |
Official labeling on DailyMed
- PENICILLIN V POTASSIUM TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-07
- PENICILLIN V POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] · version 5 · 2026-08-24
- PENICILLIN V POTASSIUM TABLET, FILM COATED [REDPHARM DRUG] · version 1 · 2026-08-17
- PENICILLIN V POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 5 · 2026-08-14
- PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC] · version 12 · 2026-08-14
- PENICILLIN V POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 10 · 2026-08-10
- PENICILLIN V POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 17 · 2026-07-30
- PENICILLIN V POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 2 · 2026-07-30
- PENICILLIN V POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-07-27
- PENICILLIN V POTASSIUM TABLET PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [CHARTWELL RX, LLC] · version 2 · 2026-07-24
- PENICILLIN V POTASSIUM TABLET, FILM COATED [REDPHARM DRUG] · version 2 · 2026-07-15
- PENICILLIN V POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] · version 6 · 2026-06-26
Showing the 12 most recent of 59 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.