Advicor
- Product NDC
- 54868-5653
- 11-digit product format
- 548685653
- Labeler code
- 54868
- Product ID
- 54868-5653_0b937ee5-f2c3-48a9-87d2-f0689ff39043
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- niacin and lovastatin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Physicians Total Care, Inc.
- Application
- NDA021249
- Marketing category
- NDA
- Marketing start
- 2006-08-08
- Marketing end
- 0000-00-00
- Substance
- NIACIN; LOVASTATIN
- Active strength
- 1000 mg/1; mg/1
- Pharmacologic classes
- Nicotinic Acid [EPC],Nicotinic Acids [CS],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 | 54868-5653 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 54868-5653 | 54868-5653-0 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 54868-5653 | 54868-5653-1 | I | Inactivated by FDA | 2026-10-05 |
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 | 54868-5653-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 54868-5653-1 | 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 | 54868-5653-0 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 54868-5653-1 | e2bbac7714bc… | 27bdfed8d636… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2dae634-14ed-febf-08ee-93196433b5b7 | Product name | 9 | 20190614 |
| 0a5e5249-329b-0cff-e714-77159f193a87 | Product name | 1 | 20140508 |
| 6b7a6f32-42a6-994d-5ab6-d180e92ee9d8 | Product name | 1 | 20140508 |
| d394f843-7479-dc48-dbd3-232266c5548c | Product name | 1 | 20140508 |
| 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 | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54868-5653-0 | 2019-09-24 | C162847 | 48780-1 | 9350213a-485f-c013-e053-90daa90a1393 | Advicor ® (niacin extended-release/lovastatin tablets) |
| 54868-5653-1 | 2019-09-24 | C162847 | 48780-1 | 9350213a-485f-c013-e053-90daa90a1393 | Advicor ® (niacin extended-release/lovastatin tablets) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54868-5653-0 | Advicor | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 4 | |
| 54868-5653-1 | Advicor | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54868-5653-0 | EA - Each | 54868-5653 | c6aedfc0-0dbb-4632-a577-175af5cc354d | 1 | 2012-07-24 |
| 54868-5653-1 | EA - Each | 54868-5653 | c682b7a3-2761-4953-879f-11cdf87af622 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54868-5653 | ADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 4 | Legacy NDC, 2 package rows | 20121008_dbdee4c0-86fa-4857-b536-79bf9ebb911a.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 791834 | Advicor 1000 MG / 20 MG 24HR Extended Release Oral Tablet | PSN | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791846 | Advicor 1000 MG / 40 MG 24HR Extended Release Oral Tablet | PSN | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791838 | Advicor 500 MG / 20 MG 24HR Extended Release Oral Tablet | PSN | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791842 | Advicor 750 MG / 20 MG 24HR Extended Release Oral Tablet | PSN | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 644112 | niacin 1000 MG / lovastatin 40 MG 24HR Extended Release Oral Tablet | PSN | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791834 | 24 HR lovastatin 20 MG / niacin 1000 MG Extended Release Oral Tablet [Advicor] | SBD | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791838 | 24 HR lovastatin 20 MG / niacin 500 MG Extended Release Oral Tablet [Advicor] | SBD | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791842 | 24 HR lovastatin 20 MG / niacin 750 MG Extended Release Oral Tablet [Advicor] | SBD | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791846 | 24 HR lovastatin 40 MG / niacin 1000 MG Extended Release Oral Tablet [Advicor] | SBD | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582041 | 24 HR lovastatin 20 MG / niacin 1000 MG Extended Release Oral Tablet | SCD | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582042 | 24 HR lovastatin 20 MG / niacin 500 MG Extended Release Oral Tablet | SCD | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582043 | 24 HR lovastatin 20 MG / niacin 750 MG Extended Release Oral Tablet | SCD | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 644112 | 24 HR lovastatin 40 MG / niacin 1000 MG Extended Release Oral Tablet | SCD | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582041 | 24 HR Lovastatin 20 MG / nicotinic acid 1000 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791834 | 24 HR Lovastatin 20 MG / nicotinic acid 1000 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582042 | 24 HR Lovastatin 20 MG / nicotinic acid 500 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791838 | 24 HR Lovastatin 20 MG / nicotinic acid 500 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582043 | 24 HR Lovastatin 20 MG / nicotinic acid 750 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791842 | 24 HR Lovastatin 20 MG / nicotinic acid 750 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582041 | 24 HR Lovastatin 20 MG / vit-B3 1000 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791834 | 24 HR Lovastatin 20 MG / vit-B3 1000 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582042 | 24 HR Lovastatin 20 MG / vit-B3 500 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791838 | 24 HR Lovastatin 20 MG / vit-B3 500 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582043 | 24 HR Lovastatin 20 MG / vit-B3 750 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791842 | 24 HR Lovastatin 20 MG / vit-B3 750 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582041 | 24 HR Lovastatin 20 MG / vitamin B3 1000 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791834 | 24 HR Lovastatin 20 MG / vitamin B3 1000 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582042 | 24 HR Lovastatin 20 MG / vitamin B3 500 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791838 | 24 HR Lovastatin 20 MG / vitamin B3 500 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582043 | 24 HR Lovastatin 20 MG / vitamin B3 750 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791842 | 24 HR Lovastatin 20 MG / vitamin B3 750 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 644112 | 24 HR Lovastatin 40 MG / nicotinic acid 1000 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791846 | 24 HR Lovastatin 40 MG / nicotinic acid 1000 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 644112 | 24 HR Lovastatin 40 MG / vit-B3 1000 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791846 | 24 HR Lovastatin 40 MG / vit-B3 1000 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 644112 | 24 HR Lovastatin 40 MG / vitamin B3 1000 MG Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791846 | 24 HR Lovastatin 40 MG / vitamin B3 1000 MG Extended Release Oral Tablet [Advicor] | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791834 | Advicor 1000/20 24 HR Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791846 | Advicor 1000/40 24 HR Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791838 | Advicor 500/20 (niacin / lovastatin) 24 HR Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791838 | Advicor 500/20 24 HR Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 791842 | Advicor 750/20 24 HR Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582041 | lovastatin 20 MG / niacin 1000 MG 24 HR Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582042 | lovastatin 20 MG / niacin 500 MG 24 HR Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 582043 | lovastatin 20 MG / niacin 750 MG 24 HR Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 644112 | lovastatin 40 MG / niacin 1000 MG 24 HR Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
| 644112 | lovastatin 40 MG / vitamin B3 1000 MG 24 HR Extended Release Oral Tablet | SY | dbdee4c0-86fa-4857-b536-79bf9ebb911a | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 54868-5653-0 | 54868565300 | 30 in 1 BOTTLE | Historical |
| 54868-5653-1 | 54868565301 | 90 in 1 BOTTLE | Historical |