Simvastatin
- Product NDC
- 72189-421
- Requested package NDC
- 72189-421-30
- 11-digit product format
- 721890421
- Labeler code
- 72189
- Product ID
- 72189-421_2c4cfec2-fee2-e007-e063-6294a90a3cf9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2023-02-07
- Substance
- SIMVASTATIN
- Active strength
- 20 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 72189-421 | 72189-421-30 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 72189-421 | 72189-421-30 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… |
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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Simvastatin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SIMVASTATIN | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| AGG2FN16EV | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312961 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f42246de-62d2-212f-e053-2a95a90ac88a | Available on FDA.report |
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 |
| 43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6 | Product name | 1 | 20160615 |
| 0a5e5249-329b-0cff-e714-77159f193a87 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72189-421-30 | Simvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 4 | |
| 72189-421-90 | Simvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-421-30 | EA - Each | 72189-421 | 4f3059ed-e026-4d71-b101-68b8e9737112 | 1 | 2023-03-13 |
| 72189-421-90 | EA - Each | 72189-421 | 3b4003ab-46f0-409a-9485-9771da360516 | 1 | 2023-04-07 |
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 |
|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 312961 | simvastatin 20 MG Oral Tablet | PSN | f42246de-62d2-212f-e053-2a95a90ac88a | 4 |
| 312961 | simvastatin 20 MG Oral Tablet | SCD | f42246de-62d2-212f-e053-2a95a90ac88a | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 72189-421-30 | 72189042130 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-421-30) | 2023-02-07 | No | No | Current |