Home Applications 065149 Application 065149
Type ANDA
Sponsor HANFORD GC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 1,000,000 UNITS/VIAL No No 002 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 5,000,000 UNITS/VIAL No No 003 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 20,000,000 UNITS/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065149-001 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 A065149-002 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 A065149-003 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 11 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PENICILLIN G POTASSIUM PENICILLIN G Baxter Healthcare Corporation 9e58122f-5c75-4905-a774-d3a4dae4ff8c 2026-07-24 Warnings, Adverse reactions Name fallback brand name: PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM HF Acquisition Co LLC, DBA HealthFirst 56ab659e-ad28-028f-e063-6394a90a6943 2026-07-15 Warnings, Adverse reactions Name fallback brand name: PENICILLIN G POTASSIUM generic name: PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM HF Acquisition Co LLC, DBA HealthFirst 50c7500f-be06-01af-e063-6294a90a0135 2026-05-01 Warnings, Adverse reactions Name fallback brand name: PENICILLIN G POTASSIUM generic name: PENICILLIN G POTASSIUM Pfizerpen PENICILLIN G POTASSIUM Roerig efef4846-9497-41af-8dd6-518f86eca7f2 2025-12-16 Warnings, Adverse reactions Name fallback generic name: PENICILLIN G POTASSIUM Penicillin G Potassium PENICILLIN G POTASSIUM Avenacy Inc. 969a421e-37d8-499e-9e89-67e210bd5d9d 2025-02-01 Warnings, Adverse reactions Name fallback brand name: Penicillin G Potassium generic name: PENICILLIN G POTASSIUM Penicillin G Potassium PENICILLIN G POTASSIUM Athenex Pharmaceutical Division, LLC. 1442486a-05d6-4dce-8b95-857a30f478c2 2025-01-28 Warnings, Adverse reactions Name fallback brand name: Penicillin G Potassium generic name: PENICILLIN G POTASSIUM Pfizerpen PENICILLIN G POTASSIUM Roerig 2f7ea103-56cc-492f-b862-af45f9aed980 2024-12-12 Warnings, Adverse reactions Name fallback generic name: PENICILLIN G POTASSIUM Pfizerpen PENICILLIN G POTASSIUM Roerig d8aaefb6-3f7d-4bc5-b40a-1c58c3054320 2024-12-10 Warnings, Adverse reactions Name fallback generic name: PENICILLIN G POTASSIUM Penicillin G Potassium PENICILLIN G POTASSIUM Sagent Pharmaceuticals fb2f3afe-0072-4383-bad8-9da9e94db4f2 2024-12-04 Warnings, Adverse reactions Name fallback brand name: Penicillin G Potassium generic name: PENICILLIN G POTASSIUM Penicillin G Potassium PENICILLIN G POTASSIUM NorthStar Rx, LLC 8732b7ff-2e47-4f99-aadf-81861b431f4f 2024-06-28 Warnings, Adverse reactions Name fallback brand name: Penicillin G Potassium generic name: PENICILLIN G POTASSIUM Penicillin G Potassium PENICILLIN G POTASSIUM Sandoz Inc 91950983-4884-40d1-abd8-bcc953d61b7f 2020-09-16 Warnings, Adverse reactions Name fallback brand name: Penicillin G Potassium generic name: PENICILLIN G POTASSIUM
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 44567-310 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-310 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-310 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-310 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-310 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-311 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-311 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-311 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-311 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-311 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-312 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-312 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-312 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-312 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current 44567-312 Penicillin G Potassium Penicillin G Potassium WG Critical Care, LLC ANDA Current