Application 050638
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 20,000 UNITS/ML | Yes | Yes |
| 002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 40,000 UNITS/ML | Yes | Yes |
| 003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 60,000 UNITS/ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | PENICILLIN G POTASSIUM | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | |
| N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | PENICILLIN G POTASSIUM | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | |
| N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | PENICILLIN G POTASSIUM | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 8072bd15b7f6… |
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.
| 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 | 050638 NDA050638 0338-1023 0338-1021 0338-1025 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-1021 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
| 0338-1021 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
| 0338-1021 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
| 0338-1021 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
| 0338-1023 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
| 0338-1023 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
| 0338-1023 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
| 0338-1023 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
| 0338-1025 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
| 0338-1025 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
| 0338-1025 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
| 0338-1025 | PENICILLIN G POTASSIUM | PENICILLIN G | Baxter Healthcare Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76224 | SUPPL | 2023-11-07 |
| 76219 | SUPPL | 2023-11-03 |
| 50557 | SUPPL | 2017-12-01 |
| 50514 | SUPPL | 2017-11-28 |
| 17959 | SUPPL | 2016-07-21 |
| 30206 | SUPPL | 2016-07-20 |
| 7914 | SUPPL | 2012-04-18 |
| 17958 | SUPPL | 2012-04-16 |
| 39062 | SUPPL | 2008-03-05 |
| 30205 | SUPPL | 2008-03-05 |
| 30204 | SUPPL | 2005-02-08 |
| 30203 | SUPPL | 2004-06-15 |
| 30202 | SUPPL | 2002-08-23 |