PRAVASTATIN SODIUM
- Product NDC
- 55801-144
- 11-digit product format
- 558010144
- Labeler code
- 55801
- Product ID
- 55801-144_6e0a1a56-f6dd-4c55-9b48-df317f5bfff6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PRAVASTATIN SODIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- APPCO PHARMA LLC
- Application
- ANDA209869
- Marketing category
- ANDA
- Marketing start
- 2018-04-13
- Marketing end
- 0000-00-00
- Substance
- PRAVASTATIN SODIUM
- Active strength
- 80 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209869-001 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2018-04-13 | |
| A209869-002 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2018-04-13 | |
| A209869-003 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2018-04-13 | |
| A209869-004 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2018-04-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209869-001 | AB |
| A209869-002 | AB |
| A209869-003 | AB |
| A209869-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A209869-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2018-04-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209869-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2018-04-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209869-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2018-04-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209869-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2018-04-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209869-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2018-04-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209869-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2018-04-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209869-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2018-04-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209869-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2018-04-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209869-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2018-04-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209869-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2018-04-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209869-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2018-04-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209869-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2018-04-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209869-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2018-04-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209869-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2018-04-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209869-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2018-04-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209869-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2018-04-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209869-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2018-04-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209869-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2018-04-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209869-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2018-04-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209869-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2018-04-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209869-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2018-04-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209869-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2018-04-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209869-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2018-04-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209869-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2018-04-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209869-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2018-04-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209869-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2018-04-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209869-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2018-04-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209869-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2018-04-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209869-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2018-04-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209869-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2018-04-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209869-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2018-04-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209869-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2018-04-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209869-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2018-04-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209869-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2018-04-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209869-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2018-04-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209869-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2018-04-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209869-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2018-04-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209869-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2018-04-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209869-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2018-04-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209869-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2018-04-13 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A209869-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209869-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209869-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209869-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209869-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209869-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209869-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209869-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209869-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209869-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209869-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209869-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209869-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209869-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209869-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209869-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209869-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209869-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209869-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209869-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209869-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209869-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209869-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209869-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209869-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209869-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209869-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209869-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209869-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209869-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209869-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209869-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209869-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209869-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209869-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209869-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209869-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209869-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209869-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209869-004 | AB | 1 | d8e5a09893c0… |
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 | Bryant Ranch Prepack | ca7a4143-0091-4cd5-9061-cb05cc84ea4e | 2026-06-16 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Bryant Ranch Prepack | f074240e-ef6b-45f2-8c4d-cb5c0dbc81f1 | 2026-06-11 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 3686a2df-51c4-4f1c-9d1e-d69207915144 | 2026-06-11 | Warnings, Adverse reactions | 209869 ANDA209869 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | d0641def-425e-4357-a6b6-24ce00424549 | 2026-06-01 | Warnings, Adverse reactions | 209869 ANDA209869 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | dcf46d0c-87da-4009-b238-eb5cf287c3ed | 2026-05-29 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Golden State Medical Supply, Inc. | 25b7276e-a69f-af63-e063-6394a90aecf2 | 2026-04-21 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Biocon Pharma Inc. | 9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb | 2026-02-26 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | A-S Medication Solutions | 2f658680-939a-4212-8a5e-a44a896dd221 | 2026-02-11 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | A-S Medication Solutions | 3b9fe7c9-791e-49a0-a005-ccf13036c365 | 2026-02-11 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Northwind Health Company, LLC | 40aa2d36-57ce-1f48-e063-6294a90affef | 2026-01-02 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Northwind Health Company, LLC | 47207487-0c6d-8da3-e063-6294a90a8aee | 2025-12-29 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 4ed7a4d1-1183-4d95-8311-6d3e58feafa8 | 2025-11-10 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f | 2025-11-10 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | A-S Medication Solutions | 33c141e9-76dc-4e32-9b2a-4621f32ac4bd | 2025-07-24 | Warnings, Adverse reactions | 209869 ANDA209869 |
| Pravastatin sodium | PRAVASTATIN SODIUM | A-S Medication Solutions | 72693449-01ee-42b0-9902-566252324579 | 2025-07-24 | Warnings, Adverse reactions | 209869 ANDA209869 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 7b7f5c28-78fa-4625-ad69-4291500e033d | 2025-05-19 | Warnings, Adverse reactions | 209869 ANDA209869 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 51800012-406b-4389-817f-88dd21e338d1 | 2025-05-19 | Warnings, Adverse reactions | 209869 ANDA209869 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | a7f75948-2958-44c8-b52f-5e39e80cdd1f | 2025-05-13 | Warnings, Adverse reactions | 209869 ANDA209869 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | e358f314-9cbe-46a4-9564-6bedc7ef9d59 | 2025-04-23 | Warnings, Adverse reactions | 209869 ANDA209869 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 80ddec55-6a18-4b87-8a07-6ae86ad62853 | 2025-04-23 | Warnings, Adverse reactions | 209869 ANDA209869 |