Lovastatin
- Product NDC
- 68071-4271
- Requested package NDC
- 68071-4271-9
- 11-digit product format
- 680714271
- Labeler code
- 68071
- Product ID
- 68071-4271_e767aa2c-50dc-bf30-e053-2995a90a4a4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA078296
- Marketing category
- ANDA
- Marketing start
- 2007-11-01
- Marketing end
- 0000-00-00
- Substance
- LOVASTATIN
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 68071-4271 | 68071-4271-9 | D | Discontinued by firm | 2026-08-17 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078296-001 | LOVASTATIN | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | |
| A078296-002 | LOVASTATIN | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | |
| A078296-003 | LOVASTATIN | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078296-001 | AB |
| A078296-002 | AB |
| A078296-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-002 | LOVASTATIN | 20MG | TABLET / ORAL | AB | 2007-11-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-003 | LOVASTATIN | 40MG | TABLET / ORAL | AB | 2007-11-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078296-001 | LOVASTATIN | 10MG | TABLET / ORAL | AB | 2008-03-14 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078296-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078296-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078296-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078296-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078296-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078296-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078296-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078296-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078296-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078296-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078296-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078296-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078296-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078296-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078296-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078296-001 | AB | 1 | 1e350fbaab3a… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 68071-4271-3 | 2021-02-16 | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 68071-4271-6 | 2021-02-16 | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 68071-4271-3 | 2021-01-29 | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 68071-4271-6 | 2021-01-29 | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
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 | PD-Rx Pharmaceuticals, Inc. | e75b5808-ec66-4da7-90bc-e53611aa1b34 | 2026-06-12 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Preferred Pharmaceuticals, Inc. | 397949f9-ce60-424f-9902-90e65a34f4de | 2026-06-03 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Preferred Pharmaceuticals, Inc. | 22c9f2d8-7bcd-4415-bbc8-505720033966 | 2026-06-03 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Bryant Ranch Prepack | 030c0f79-6bb5-4876-bf8e-b7a25b25dd38 | 2026-05-29 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Bryant Ranch Prepack | f5f265a6-2aa5-4205-9159-40133ae93ac0 | 2026-05-28 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | BluePoint Laboratories | 7b86160d-74a9-4774-b5b3-5641e686991f | 2026-05-27 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | REMEDYREPACK INC. | ff040b3c-6790-40d7-bd64-a4073b4a2045 | 2026-05-21 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Lupin Pharmaceuticals, Inc. | df7ddf4f-d569-431e-81f1-9129d7043150 | 2026-05-06 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Legacy Pharmaceutical Packaging, LLC | a4f02fa1-3281-46fa-bd52-323e2644b6f8 | 2026-03-11 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Northwind Health Company, LLC | f308fe1c-23a9-6409-e053-2995a90abfd9 | 2026-01-01 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Northwind Health Company, LLC | ca59cbd4-a4c1-aebe-e053-2a95a90ae968 | 2026-01-01 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Northwind Health Company, LLC | f99e0b4c-e757-4ccd-e053-6294a90ab722 | 2026-01-01 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | A-S Medication Solutions | 06b8c398-ce2e-42c1-b1a8-73cc59a080db | 2025-10-15 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 2eeb34ac-f973-e7d9-e063-6294a90a076e | 2025-02-24 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | NuCare Pharmaceuticals, Inc. | 50217921-97a7-6ff2-e054-00144ff88e88 | 2025-02-04 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | A-S Medication Solutions | 02aae38d-ee9d-4c09-a155-b69f221ed3e9 | 2024-10-15 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | NCS HealthCare of KY, LLC dba Vangard Labs | 3af47e72-082d-42ad-bde0-294f8101b45c | 2024-08-05 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | NuCare Pharmaceuticals,Inc. | 19b2bb87-1dc7-cd72-e063-6394a90a0f73 | 2024-06-18 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | NuCare Pharmaceuticals,Inc. | 1ac7ffb9-860a-fbb6-e063-6294a90a590f | 2024-06-13 | Warnings, Adverse reactions | 078296 ANDA078296 |
| Lovastatin | LOVASTATIN | Proficient Rx LP | 2b53ab6a-5770-4fd7-9aa1-f4273d4bdaeb | 2022-12-01 | Warnings, Adverse reactions | 078296 ANDA078296 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-4271-9 | 68071427109 | 90 TABLET in 1 BOTTLE (68071-4271-9) | 90 tablet | 2018-02-06 | 0000-00-00 | No | No | Current |