Pravastatin Sodium
- Product NDC
- 66116-346
- 11-digit product format
- 661160346
- Labeler code
- 66116
- Product ID
- 66116-346_dad83d68-f35a-42ca-a65c-f95677e1c9ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pravastatin Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- MedVantx, Inc.
- Application
- ANDA076056
- Marketing category
- ANDA
- Marketing start
- 2006-04-25
- Marketing end
- 0000-00-00
- Substance
- PRAVASTATIN SODIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 product | product | 66116-346 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 66116-346 | 66116-346-30 | I | Inactivated by FDA | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 66116-346-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 66116-346-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 66116-346-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 66116-346-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 66116-346-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 66116-346-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 66116-346-30 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 66116-346-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 66116-346-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 66116-346-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 66116-346-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 66116-346-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 66116-346-30 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 66116-346-30 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 66116-346-30 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 66116-346-30 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 66116-346-30 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 66116-346-30 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 66116-346-30 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 66116-346-30 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 66116-346-30 | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 66116-346-30 | 110d247fa046… | a55b01930146… |
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 Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 36361c23-a766-1581-d616-2080c781a50c | Product name | 5 | 20190314 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66116-346-30 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-50a3-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use pravastatin sodium tablets USP safely and effectively. See full prescribing information for pravastatin sodium tablets USP. PRAVASTATIN SODIUM tablets USP for oral use Initial U.S. Approval: 1991 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66116-346-30 | Pravastatin Sodium | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PRAVASTATIN SODIUM | ACTIVE INGREDIENT | 3M8608UQ61 | PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| PRAVASTATIN | ACTIVE MOIETY | KXO2KT9N0G | PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | PRAVASTATIN SODIUM TABLET [MEDVANTX, INC.] | 1 |
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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904467 | pravastatin sodium 20 MG Oral Tablet | PSN | dad83d68-f35a-42ca-a65c-f95677e1c9ca | 1 |
| 904467 | pravastatin sodium 20 MG Oral Tablet | SCD | dad83d68-f35a-42ca-a65c-f95677e1c9ca | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 66116-346-30 | 66116034630 | 30 in 1 BOTTLE | Historical |