FDA Orange Book · active-ingredient family
Penicillin g potassium
Penicillin g potassium is approved as 1 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PENICILLIN G POTASSIUM IN PLASTIC CONTAINER · NDA 050638
1
Brand (NDA)
26
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PENICILLIN G POTASSIUM IN PLASTIC CONTAINERRLD×3 | BAXTER HLTHCARE | NDA 050638 | — | Jun 25, 1990 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PENICILLIN G POTASSIUM×2 | ACS DOBFAR SPA | ANDA 205043 | AP | Oct 26, 2018 | |
| PENICILLIN G POTASSIUM×2 | ISTITUTO BIO ITA SPA | ANDA 065448 | AP | Aug 18, 2009 | |
| PENICILLIN G POTASSIUM×3 | HQ SPECLT PHARMA | ANDA 065149 | — | Jul 23, 2009 | |
| PENICILLIN G POTASSIUM×3 | SANDOZ | ANDA 065079 | — | Aug 30, 2002 | |
| PENICILLIN G POTASSIUM×4 | WATSON LABS INC | ANDA 062991 | — | Sep 13, 1988 | |
| PENICILLIN×3 | TEVA | ANDA 060307 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM×3 | MYLAN | ANDA 060752 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM×2 | PUREPAC PHARM | ANDA 061740 | — | Approved Prior to Jan 1, 1982 | |
| PENTIDS '200'×2 | APOTHECON | ANDA 062149 | — | Approved Prior to Jan 1, 1982 | |
| PFIZERPEN G | PFIZER | ANDA 060587 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM×4 | APOTHECON | ANDA 060362 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM×4 | CONSOLIDATED PHARM | ANDA 060806 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM×5 | LILLY | ANDA 060384 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM | LILLY | ANDA 060601 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM×2 | PARKE DAVIS | ANDA 062003 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM | PFIZER | ANDA 060074 | — | Approved Prior to Jan 1, 1982 | |
| PFIZERPEN×3 | PFIZER | ANDA 060657 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM×3 | APOTHECON | ANDA 060392 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM | IVAX SUB TEVA PHARMS | ANDA 060073 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM | LILLY | ANDA 060403 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM×5 | MYLAN | ANDA 060781 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM×3 | PUREPAC PHARM | ANDA 061588 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM×4 | TEVA | ANDA 060306 | — | Approved Prior to Jan 1, 1982 | |
| PENICILLIN G POTASSIUM×3 | WYETH AYERST | ANDA 060413 | — | Approved Prior to Jan 1, 1982 | |
| PENTIDS '200'×4 | APOTHECON | ANDA 062155 | — | Approved Prior to Jan 1, 1982 | |
| PFIZERPEN G×6 | PFIZER | ANDA 060075 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Penicillin g potassium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

