LOVASTATIN
- Product NDC
- 61919-547
- Requested package NDC
- 61919-547-90
- 11-digit product format
- 619190547
- Labeler code
- 61919
- Product ID
- 61919-547_b8b65187-6bbb-18ef-e053-2a95a90aa01f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LOVASTATIN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA075991
- Marketing category
- ANDA
- Marketing start
- 2019-08-21
- Marketing end
- 0000-00-00
- Substance
- LOVASTATIN
- Active strength
- 20 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 | 61919-547 | 61919-547-90 | 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075991-001 | LOVASTATIN | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | |
| A075991-002 | LOVASTATIN | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | |
| A075991-003 | LOVASTATIN | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075991-001 | AB |
| A075991-002 | AB |
| A075991-003 | 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 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075991-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2002-06-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075991-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | RS | 2002-06-05 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075991-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2002-06-05 | 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 | A075991-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075991-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075991-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075991-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075991-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075991-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075991-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075991-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075991-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075991-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075991-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075991-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075991-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075991-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075991-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075991-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075991-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075991-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075991-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075991-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075991-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075991-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075991-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075991-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075991-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075991-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075991-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075991-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075991-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075991-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075991-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075991-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075991-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075991-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075991-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075991-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075991-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075991-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075991-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075991-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dc9a5fb6-14e2-1cc8-a567-a781fd1f0212 | Product name | 1 | 20140508 |
| f1ae760e-e8ec-b0b4-fb1b-2db7c49fcec5 | Product name | 1 | 20140508 |
| fecc3d5d-ff9a-60ad-1a3a-6cb9b21df758 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Indexing SPL | Related label |
|---|---|---|---|
| 61919-547-71 | 2025-01-30 | 2cef2736-a3a9-d83d-e063-dadaa90ab31f | LOVASTATIN |
| 61919-547-30 | 2024-01-30 | 9d75b9d0-b95f-f424-e053-dadaa90a57ce | LOVASTATIN |
| 61919-547-90 | 2024-01-30 | 9d75b9d0-b95f-f424-e053-dadaa90a57ce | LOVASTATIN |
| 61919-547-30 | 2021-01-12 | 9d75b9d0-b95f-f424-e053-dadaa90a57ce | LOVASTATIN |
| 61919-547-90 | 2021-01-12 | 9d75b9d0-b95f-f424-e053-dadaa90a57ce | LOVASTATIN |
| 61919-547-30 | 2020-01-31 | 9d75b9d0-b95f-f424-e053-dadaa90a57ce | LOVASTATIN |
| 61919-547-90 | 2020-01-31 | 9d75b9d0-b95f-f424-e053-dadaa90a57ce | LOVASTATIN |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-547-30 | LOVASTATIN | 30 in 1 BOTTLE | TABLET | 30 | 6 | |
| 61919-547-90 | LOVASTATIN | 90 in 1 BOTTLE | TABLET | 90 | 6 | |
| 61919-547-71 | LOVASTATIN | 100 in 1 BOTTLE | TABLET | 100 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-547-30 | EA - Each | 61919-547 | 3fc0b862-6252-4178-a98f-9160814a27e4 | 1 | 2016-11-08 |
| 61919-547-71 | EA - Each | 61919-547 | b9016103-fe57-4950-b119-5b48fbd105c7 | 1 | 2019-09-05 |
| 61919-547-90 | EA - Each | 61919-547 | 677d1215-032c-4344-8307-ca8a185d2876 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LOVASTATIN | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [DIRECT RX] | 1 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [DIRECT RX] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [DIRECT RX] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [DIRECT RX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [DIRECT RX] | 1 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | LOVASTATIN TABLET [DIRECT RX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LOVASTATIN TABLET [DIRECT RX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [DIRECT RX] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LOVASTATIN TABLET [DIRECT RX] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-547 | LOVASTATIN TABLET [DIRECT RX] | 6 | Legacy NDC, 2 package rows | 20210113_b2f17323-2e08-462a-9a91-42f22bcaf53c.zip |
| 61919-547 | LOVASTATIN TABLET [DIRECT_RX] | 4 | Legacy NDC, 1 package rows | 20230510_90a27c1d-3f44-e51e-e053-2a95a90a9e7b.zip |
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 |
|---|---|---|---|---|---|---|
| Lovastatin | LOVASTATIN | REMEDYREPACK INC. | 9438d8a0-ca5b-4676-aab9-d0241ccff6c9 | 2026-07-23 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | Preferred Pharmaceuticals Inc. | 56680dfa-abe6-4587-b222-364315fd78f4 | 2026-06-03 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | Preferred Pharmaceuticals, Inc. | ea4df37b-21e9-4dc3-83af-1be1b50bfdc9 | 2026-06-03 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | Bryant Ranch Prepack | 7fd9d5c7-8025-4049-8b5b-ae3d22db507f | 2026-03-09 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | Northwind Health Company, LLC | db47ddae-c574-427f-e053-2a95a90aae48 | 2026-01-01 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | A-S Medication Solutions | dd7a223e-7fc5-4eb0-9bd7-2f9a2d6b4173 | 2025-10-10 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | A-S Medication Solutions | bfb889a4-5751-4706-9fa7-f48672c1bc08 | 2025-10-10 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | Bryant Ranch Prepack | 220a9b3c-c583-49e3-8bf0-d0c97dc9b829 | 2025-04-01 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | PD-Rx Pharmaceuticals, Inc. | c37206ae-52f1-4192-9ab9-3044247cf58d | 2025-03-13 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | PD-Rx Pharmaceuticals, Inc. | ac86821f-d741-4ab1-bd03-ce8797dd4f34 | 2025-03-12 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | PD-Rx Pharmaceuticals, Inc. | 70e2bf86-4a78-4dfb-b6b1-8eb95f63684d | 2025-03-06 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | PD-Rx Pharmaceuticals, Inc. | eea93a4b-f804-4b9c-aabf-e906f03c1e80 | 2025-02-28 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 2eff3e5e-8746-048e-e063-6294a90a38c4 | 2025-02-25 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | Carlsbad Technology, Inc. | 0a680e13-0356-4e08-a7fe-78b96ba51b9d | 2025-01-07 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | Bryant Ranch Prepack | c871a6a7-67a4-4ac1-b102-3f1604625c7d | 2024-09-12 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | NuCare Pharmaceuticals, Inc. | 415c2698-7787-49f8-e054-00144ff88e88 | 2024-08-14 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | NuCare Pharmaceuticals, Inc. | 4444573e-9df1-01e6-e054-00144ff8d46c | 2024-08-14 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | Bryant Ranch Prepack | 8d8199ca-df39-4eb8-a905-dee3ab7e2973 | 2024-08-14 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | Bryant Ranch Prepack | 5684ceb8-a5b2-4fb4-92be-14aabcea3871 | 2024-08-09 | Warnings, Adverse reactions | 075991 ANDA075991 |
| Lovastatin | LOVASTATIN | Bryant Ranch Prepack | ad905651-6e3a-4140-aa37-d91e5f37c0f0 | 2024-08-08 | Warnings, Adverse reactions | 075991 ANDA075991 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197904 | lovastatin 20 MG Oral Tablet | PSN | b2f17323-2e08-462a-9a91-42f22bcaf53c | 6 |
| 197904 | lovastatin 20 MG Oral Tablet | SCD | b2f17323-2e08-462a-9a91-42f22bcaf53c | 6 |
| 197904 | lovastatin 20 MG Oral Tablet | PSN | 90a27c1d-3f44-e51e-e053-2a95a90a9e7b | 4 |
| 197904 | lovastatin 20 MG Oral Tablet | SCD | 90a27c1d-3f44-e51e-e053-2a95a90a9e7b | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-547-90 | 61919054790 | 90 TABLET in 1 BOTTLE (61919-547-90) | 90 tablet | 2015-11-09 | 0000-00-00 | No | No | Current |