Penicillin V Potassium
- Product NDC
- 53002-2130
- Requested package NDC
- 53002-2130-1
- 11-digit product format
- 530022130
- Labeler code
- 53002
- Product ID
- 53002-2130_42f409a1-2330-4d44-a6f2-706f2e6d75fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Penicillin V Potassium
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA060456
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 0000-00-00
- Substance
- PENICILLIN V POTASSIUM
- Active strength
- 250 mg/5mL
- Pharmacologic classes
- Penicillins [CS],Penicillin-class Antibacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 53002-2130 | 53002-2130-1 | I | Inactivated by FDA | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A060456-001 | PENICILLIN-VK | PENICILLIN V POTASSIUM | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | ||
| A060456-002 | PENICILLIN-VK | PENICILLIN V POTASSIUM | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | RS, Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A060456-001 | PENICILLIN-VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | A060456-002 | PENICILLIN-VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | RS, Approved before 1982 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Penicillin V Potassium | PENICILLIN V POTASSIUM | Chartwell RX, LLC | b0744674-ddf7-4022-be2f-2a22bef0d379 | 2026-07-23 | Warnings, Adverse reactions | 060456 ANDA060456 |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | Preferred Pharmaceuticals, Inc | 8c342c78-47fb-4f6b-9451-68b1f752555c | 2025-09-08 | Warnings, Adverse reactions | 060456 ANDA060456 |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | NuCare Pharmaceuticals,Inc. | 55a44735-6d6e-3012-e054-00144ff8d46c | 2024-12-31 | Warnings, Adverse reactions | 060456 ANDA060456 |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | A-S Medication Solutions | ded0ee2e-56ae-41fe-949c-177614cd8e1f | 2023-09-25 | Warnings, Adverse reactions | 060456 ANDA060456 |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | Teva Pharmaceuticals USA, Inc. | 3111ca84-6f8e-45ea-91a1-9cb99c63607e | 2023-01-31 | Warnings, Adverse reactions | 060456 ANDA060456 |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | Proficient Rx LP | 316aa904-09f1-4a8e-9adf-93cfc14f9a0a | 2019-11-01 | Warnings, Adverse reactions | 060456 ANDA060456 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9c9e02f7-1420-b137-8de0-89820016e6ca | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-2130-1 | Penicillin V Potassium | 100 mL in 1 BOTTLE | POWDER, FOR SOLUTION | 100 | 5 | |
| 53002-2130-2 | Penicillin V Potassium | 200 mL in 1 BOTTLE | POWDER, FOR SOLUTION | 200 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-2130 | PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 2 package rows | 20230609_465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 834040 | penicillin V potassium 250 MG in 5 mL Oral Solution | PSN | 465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd | 5 |
| 834040 | penicillin V potassium 50 MG/ML Oral Solution | SCD | 465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd | 5 |
| 834040 | Penicillin V K+ 50 MG/ML Oral Solution | SY | 465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd | 5 |
| 834040 | Penicillin V Pot 50 MG/ML Oral Solution | SY | 465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd | 5 |
| 834040 | penicillin V potassium 250 MG per 5 ML Oral Solution | SY | 465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd | 5 |
| 834040 | phenoxymethylpenicillin potassium 50 MG/ML Oral Solution | SY | 465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-2130-1 | 53002213001 | 100 mL in 1 BOTTLE (53002-2130-1) | 100 ml | 2018-10-01 | 0000-00-00 | No | No | Current |