Pravastatin Sodium
- Product NDC
- 43353-964
- Requested package NDC
- 43353-964-45
- 11-digit product format
- 433530964
- Labeler code
- 43353
- Product ID
- 43353-964_0d6fa0b8-bef8-42ff-8b4e-ea21b291a8e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pravastatin Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076056
- Marketing category
- ANDA
- Marketing start
- 2014-06-17
- Marketing end
- 0000-00-00
- Substance
- PRAVASTATIN SODIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 43353-964 | 43353-964-45 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076056-001 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | |
| A076056-002 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | |
| A076056-003 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076056-001 | AB |
| A076056-002 | AB |
| A076056-003 | AB |
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 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076056-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-04-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076056-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-04-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076056-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-04-24 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076056-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076056-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076056-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076056-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076056-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076056-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076056-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076056-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076056-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076056-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076056-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076056-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076056-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076056-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076056-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076056-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076056-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076056-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076056-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076056-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076056-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076056-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076056-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076056-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076056-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076056-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076056-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076056-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076056-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076056-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076056-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076056-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076056-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076056-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076056-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076056-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076056-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076056-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076056-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076056-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-964-45 | EA - Each | 43353-964 | 4f229adc-2bb1-411d-92cf-1ac5dbf57ace | 1 | 2016-07-19 |
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 |
|---|---|---|---|---|---|---|
| Pravastatin Sodium | PRAVASTATIN SODIUM | REMEDYREPACK INC. | 0c4b59f1-92a8-44f8-8b4c-691f35777460 | 2026-07-30 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin Sodium | PRAVASTATIN SODIUM | Cardinal Health 107, LLC | ca779f66-4b9d-41da-ad0e-e4f58db9fbac | 2026-07-10 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Safecor Health LLC | 0ae196a4-be3d-4cd8-9ff2-68aeb91b8678 | 2026-07-01 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin sodium | PRAVASTATIN SODIUM | A-S Medication Solutions | b7f8c679-a602-4268-81b6-962a136a4e43 | 2026-04-02 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin sodium | PRAVASTATIN SODIUM | A-S Medication Solutions | 8df47d82-5b09-414d-99f1-7ac4c77f7c01 | 2026-04-02 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin Sodium | PRAVASTATIN SODIUM | Northwind Health Company, LLC | f6ddb6c0-d0b4-2297-e053-6294a90a83c9 | 2026-01-01 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Northwind Health Company, LLC | 471b4dac-057d-740c-e063-6294a90af9e9 | 2025-12-19 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Preferred Pharmaceuticals Inc. | f92e12bc-40c3-4afa-9190-2f4de11ec6b3 | 2025-12-08 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Preferred Pharmaceuticals Inc. | e6a3d99c-c9cc-49d9-b0f9-503770307b70 | 2025-10-31 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin sodium | PRAVASTATIN SODIUM | NuCare Pharmaceuticals, Inc. | 3ef390a6-e0a0-331d-e063-6394a90a83d0 | 2025-10-27 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin sodium | PRAVASTATIN SODIUM | REMEDYREPACK INC. | fa152ce7-6c07-4aaf-9374-932ce81d0cf9 | 2025-10-02 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin sodium | PRAVASTATIN SODIUM | REMEDYREPACK INC. | 6cef5e92-26b7-435c-878f-72a05a624560 | 2025-08-25 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin Sodium | PRAVASTATIN SODIUM | Preferred Pharmaceuticals Inc. | 7abc1825-182d-40bc-9f7f-968e197b4246 | 2025-04-30 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin Sodium | PRAVASTATIN SODIUM | Mylan Institutional Inc. | 1b00f510-c86d-46f6-b427-311a8fd14955 | 2025-03-24 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Aurobindo Pharma Limited | cf6f7031-33b9-40d3-bc87-32f1b6af98f2 | 2025-02-18 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin Sodium | PRAVASTATIN SODIUM | NuCare Pharmaceuticals, Inc. | 2d40e473-f79a-e50e-e063-6294a90a4d9e | 2025-02-03 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin Sodium | PRAVASTATIN SODIUM | A-S Medication Solutions | 55f8cf43-bf8b-4729-9e5a-32fcc9696e02 | 2024-10-30 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin Sodium | PRAVASTATIN SODIUM | Teva Pharmaceuticals USA, Inc. | 99e0e848-f8f3-4b42-b880-8fbc42633948 | 2024-01-01 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin Sodium | PRAVASTATIN SODIUM | A-S Medication Solutions | 4f9ada33-5592-4780-926d-1af49a8e064e | 2023-12-15 | Warnings, Adverse reactions | 076056 ANDA076056 |
| Pravastatin Sodium | PRAVASTATIN SODIUM | Proficient Rx LP | 466e2d1a-a6d6-40f8-a9f6-3e7494a34ca6 | 2023-08-01 | Warnings, Adverse reactions | 076056 ANDA076056 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43353-964-45 | 43353096445 | 45 TABLET in 1 BOTTLE (43353-964-45) | 45 tablet | 2014-09-26 | 0000-00-00 | No | No | Current |