SIMVASTATIN
- Product NDC
- 68071-2250
- Requested package NDC
- 68071-2250-3
- 11-digit product format
- 680712250
- Labeler code
- 68071
- Product ID
- 68071-2250_adf42271-76c1-0fd2-e053-2995a90af7eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals.Inc.
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2016-02-19
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 68071-2250 | 68071-2250-3 | 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 | 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… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | bd6a592717d7… | 303034d00443… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078103-001 | SIMVASTATIN | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2007-05-11 | |
| A078103-002 | SIMVASTATIN | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2007-05-11 | |
| A078103-003 | SIMVASTATIN | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2007-05-11 | |
| A078103-004 | SIMVASTATIN | SIMVASTATIN | 80MG | TABLET / ORAL | AB | RS | 2007-05-11 |
| A078103-005 | SIMVASTATIN | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2009-04-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078103-001 | AB |
| A078103-002 | AB |
| A078103-003 | AB |
| A078103-004 | AB |
| A078103-005 | 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 | A078103-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2007-05-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078103-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2007-05-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078103-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2007-05-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078103-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | RS | 2007-05-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078103-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2009-04-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078103-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2007-05-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078103-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2007-05-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078103-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2007-05-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078103-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | RS | 2007-05-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078103-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2009-04-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078103-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2007-05-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078103-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2007-05-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078103-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2007-05-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078103-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | RS | 2007-05-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078103-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2009-04-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078103-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2007-05-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078103-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2007-05-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078103-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2007-05-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078103-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | RS | 2007-05-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078103-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2009-04-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078103-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2007-05-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078103-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2007-05-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078103-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2007-05-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078103-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | RS | 2007-05-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078103-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2009-04-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078103-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2007-05-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078103-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2007-05-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078103-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2007-05-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078103-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | RS | 2007-05-11 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078103-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2009-04-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078103-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2007-05-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078103-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2007-05-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078103-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2007-05-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078103-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | RS | 2007-05-11 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078103-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2009-04-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078103-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2007-05-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078103-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2007-05-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078103-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2007-05-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078103-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | RS | 2007-05-11 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078103-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2009-04-14 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078103-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078103-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078103-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078103-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078103-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078103-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078103-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078103-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078103-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078103-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078103-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078103-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078103-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078103-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078103-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078103-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078103-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078103-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078103-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078103-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078103-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078103-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078103-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078103-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078103-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078103-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078103-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078103-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078103-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078103-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078103-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078103-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078103-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078103-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078103-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078103-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078103-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078103-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078103-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078103-005 | AB | 1 | 5bbf6a4d5a75… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5347abc9-d72b-9efb-f582-cc87efafcf1b | Product name | 4 | 20250729 |
| c4422d73-8e69-1539-606a-32a25fa00ebc | Product name | 4 | 20190926 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6 | Product name | 1 | 20160615 |
| 0a5e5249-329b-0cff-e714-77159f193a87 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-2250-3 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-607c-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2250-3 | SIMVASTATIN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2250 | SIMVASTATIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS.INC.] | 1 | Legacy NDC, 1 package rows | 20200829_adf42271-76c0-0fd2-e053-2995a90af7eb.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 |
|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | e447cc46-adee-4126-8b85-f00f81a6e93c | 2026-07-08 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | f94d5907-737e-df67-e053-6394a90a82a6 | 2026-07-01 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | faa81817-3ffa-b83c-e053-6294a90a3f85 | 2026-06-02 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | f94e5e28-f0b1-700a-e053-6394a90adb7b | 2026-06-01 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | Coupler LLC | 5257271e-5c07-4996-e063-6394a90a4424 | 2026-05-21 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | Coupler LLC | 52573b98-6e51-9753-e063-6294a90ac8c4 | 2026-05-21 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | REMEDYREPACK INC. | 5ae78a86-ccca-4714-b77e-7bc885b674b5 | 2026-05-20 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | QPharma, Inc | f71fc0ac-223e-18c1-e053-6394a90a45ca | 2026-05-11 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | Coupler LLC | 50733b85-067d-99c3-e063-6394a90a4244 | 2026-04-27 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | Bryant Ranch Prepack | 5c760852-800b-463e-8059-06a9a82c2225 | 2026-04-15 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | Bryant Ranch Prepack | 7abc03f8-9d5f-4f7d-9e32-fc463ec0597c | 2026-04-15 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | REMEDYREPACK INC. | e59bf31f-d880-4d9e-b6c2-5a18a53718f9 | 2026-04-08 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | e4d8ebf3-7f9f-4725-a104-1d1bf6e6f768 | 2026-03-23 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | 0ccb324f-877d-4f32-a769-7cd1637b7fad | 2026-03-23 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | PD-Rx Pharmaceuticals, Inc. | 00896fff-081d-4553-be8c-1999a8a73dda | 2026-02-26 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | PD-Rx Pharmaceuticals, Inc. | 143bf1d6-11c5-4a1f-b106-844e0435ee13 | 2026-02-26 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | PD-Rx Pharmaceuticals, Inc. | 25d9f841-31d8-4514-ac73-ffe138ff69c7 | 2026-02-26 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | Bryant Ranch Prepack | aaca7284-d2d8-42e3-b153-ddc3d2ce907c | 2026-02-10 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | Bryant Ranch Prepack | 76ea62f3-4efb-4649-829d-3f0c28d5dae7 | 2026-02-05 | Warnings, Adverse reactions | 078103 ANDA078103 |
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | d099d003-4c7c-4e35-ad6e-94ddf20035b7 | 2026-02-03 | Warnings, Adverse reactions | 078103 ANDA078103 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198211 | simvastatin 40 MG Oral Tablet | PSN | adf42271-76c0-0fd2-e053-2995a90af7eb | 1 |
| 198211 | simvastatin 40 MG Oral Tablet | SCD | adf42271-76c0-0fd2-e053-2995a90af7eb | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-2250-3 | 68071225003 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-2250-3) | 2020-08-28 | 0000-00-00 | No | No | Current |