PENICILLIN G POTASSIUM
- Product NDC
- 0338-1021
- Requested package NDC
- 0338-1021-41
- 11-digit product format
- 003381021
- Labeler code
- 0338
- Product ID
- 0338-1021_37390720-ea2c-49a7-b88a-ad72497713c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PENICILLIN G
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- NDA050638
- Marketing category
- NDA
- Marketing start
- 1990-06-25
- Marketing end
- 0000-00-00
- Substance
- PENICILLIN G POTASSIUM
- Active strength
- 1000000 [iU]/50mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0338-1021 | 0338-1021-41 | D | Discontinued by firm | 2026-10-05 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050638-001 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050638-002 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 40,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050638-003 | PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | 60,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 1990-06-25 | caaa826d4ba7… | |
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| ea092e41-01a8-4781-b199-b94446808a52 | Product name | 1 | 20190205 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| af7816cd-473e-4681-8ef5-5d4b569ced61 | Product name | 1 | 20151014 |
| b37c02b5-6cf5-47fd-aab5-d510a02bbac0 | Product name | 1 | 20151014 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 0f47357f-4a94-e9f0-4fab-2eb6732c6263 | Product name | 1 | 20140508 |
| 11e45d82-8b7a-98b7-67b2-842a15f88536 | Product name | 1 | 20140508 |
| 6ccfe771-a97a-e261-3fb2-bf8e525d1fe0 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0338-1021-41 | PENICILLIN G POTASSIUM | 50 mL in 1 BAG | INJECTION, SOLUTION | 50 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-1021-41 | ML - Milliliter | 0338-1021 | 62210427-c92c-4c60-bbd3-852d8ef9ad2d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 0338-1021-41 0338-1021 00338102141 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 207390 | penicillin G potassium 1,000,000 UNT in 50 ML Injection | PSN | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 204466 | penicillin G potassium 2,000,000 UNT in 50 ML Injection | PSN | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 207391 | penicillin G potassium 3,000,000 UNT in 50 ML Injection | PSN | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 207390 | 50 ML penicillin G potassium 20000 UNT/ML Injection | SCD | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 204466 | 50 ML penicillin G potassium 40000 UNT/ML Injection | SCD | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 207391 | 50 ML penicillin G potassium 60000 UNT/ML Injection | SCD | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 207390 | 50 ML Penicillin G K+ 20000 UNT/ML Injection | SY | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 204466 | 50 ML Penicillin G K+ 40000 UNT/ML Injection | SY | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 207391 | 50 ML Penicillin G K+ 60000 UNT/ML Injection | SY | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 207390 | 50 ML Penicillin G Pot 20000 UNT/ML Injection | SY | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 204466 | 50 ML Penicillin G Pot 40000 UNT/ML Injection | SY | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 207391 | 50 ML Penicillin G Pot 60000 UNT/ML Injection | SY | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 207390 | penicillin G potassium 1,000,000 UNT per 50 ML Injection | SY | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 204466 | penicillin G potassium 2,000,000 UNT per 50 ML Injection | SY | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
| 207391 | penicillin G potassium 3,000,000 UNT per 50 ML Injection | SY | 9e58122f-5c75-4905-a774-d3a4dae4ff8c | 17 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0338-1021-41 | 00338102141 | 50 mL in 1 BAG (0338-1021-41) | 50 ml | 1990-06-25 | 0000-00-00 | No | No | Current |