Atorvastatin calcium
- Product NDC
- 68788-8298
- Requested package NDC
- 68788-8298-9
- 11-digit product format
- 687888298
- Labeler code
- 68788
- Product ID
- 68788-8298_716ed987-055a-42bc-90ef-c62f78ed85f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA213853
- Marketing category
- ANDA
- Marketing start
- 2022-11-29
- Marketing end
- 0000-00-00
- Substance
- ATORVASTATIN
- 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 | 68788-8298 | 68788-8298-9 | D | Discontinued by firm | 2026-08-11 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213853-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2020-08-19 | |
| A213853-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2020-08-19 | |
| A213853-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2020-08-19 | |
| A213853-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2020-08-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213853-001 | AB |
| A213853-002 | AB |
| A213853-003 | AB |
| A213853-004 | 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 | A213853-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | BX | 2020-08-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213853-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | BX | 2020-08-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213853-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | BX | 2020-08-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213853-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | BX | 2020-08-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213853-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | BX | 2020-08-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213853-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | BX | 2020-08-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213853-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | BX | 2020-08-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213853-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | BX | 2020-08-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213853-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | BX | 2020-08-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213853-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | BX | 2020-08-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213853-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | BX | 2020-08-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213853-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | BX | 2020-08-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213853-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | BX | 2020-08-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213853-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | BX | 2020-08-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213853-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | BX | 2020-08-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213853-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | BX | 2020-08-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213853-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | BX | 2020-08-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213853-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | BX | 2020-08-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213853-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | BX | 2020-08-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213853-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | BX | 2020-08-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213853-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | BX | 2020-08-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213853-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | BX | 2020-08-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213853-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | BX | 2020-08-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213853-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | BX | 2020-08-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213853-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | BX | 2020-08-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213853-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | BX | 2020-08-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213853-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | BX | 2020-08-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213853-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | BX | 2020-08-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213853-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | BX | 2020-08-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213853-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | BX | 2020-08-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213853-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | BX | 2020-08-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213853-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | BX | 2020-08-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213853-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | BX | 2020-08-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213853-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | BX | 2020-08-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213853-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | BX | 2020-08-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213853-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | BX | 2020-08-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213853-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | BX | 2020-08-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213853-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | BX | 2020-08-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213853-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | BX | 2020-08-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213853-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | BX | 2020-08-19 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213853-001 | BX | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213853-002 | BX | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213853-003 | BX | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213853-004 | BX | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213853-001 | BX | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213853-002 | BX | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213853-003 | BX | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213853-004 | BX | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213853-001 | BX | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213853-002 | BX | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213853-003 | BX | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213853-004 | BX | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213853-001 | BX | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213853-002 | BX | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213853-003 | BX | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213853-004 | BX | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213853-001 | BX | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213853-002 | BX | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213853-003 | BX | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213853-004 | BX | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213853-001 | BX | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213853-002 | BX | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213853-003 | BX | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213853-004 | BX | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213853-001 | BX | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213853-002 | BX | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213853-003 | BX | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213853-004 | BX | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213853-001 | BX | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213853-002 | BX | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213853-003 | BX | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213853-004 | BX | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213853-001 | BX | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213853-002 | BX | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213853-003 | BX | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213853-004 | BX | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213853-001 | BX | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213853-002 | BX | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213853-003 | BX | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213853-004 | BX | 1 | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8298-1 | EA - Each | 68788-8298 | 5e56d58e-c4ef-4610-8293-5c12c70d249d | 1 | 2023-01-09 |
| 68788-8298-3 | EA - Each | 68788-8298 | 3d46adcf-f8d3-483a-804a-fdd54fccfc5a | 1 | 2023-01-09 |
| 68788-8298-6 | EA - Each | 68788-8298 | c9edea22-ce78-41ce-a681-655b81c13b0e | 1 | 2023-01-09 |
| 68788-8298-9 | EA - Each | 68788-8298 | a9ca48ef-478a-416a-9c71-389e27806b7b | 1 | 2023-01-09 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8298 | ATORVASTATIN CALCIUM TABLET [PREFERRED PHARMACEUTICALS INC.] | 4 | Legacy NDC | 20250207_716ed987-055a-42bc-90ef-c62f78ed85f4.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 |
|---|---|---|---|---|---|---|
| Atorvastatin calcium | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | 6600f22e-d303-4fe3-8212-accd6fb06e62 | 2026-06-09 | Warnings, Adverse reactions | 213853 ANDA213853 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | 8821431a-c387-4b75-9540-f92bd455e961 | 2026-06-05 | Warnings, Adverse reactions | 213853 ANDA213853 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 20f820ba-9600-4b51-bf23-8c99e815674c | 2026-05-06 | Warnings, Adverse reactions | 213853 ANDA213853 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 112ae40c-b612-405b-8f68-6d4bf09f9440 | 2026-04-13 | Warnings, Adverse reactions | 213853 ANDA213853 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Direct_Rx | 0e24e7cb-1949-6686-e063-6394a90a4760 | 2026-03-06 | Warnings, Adverse reactions | 213853 ANDA213853 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | Umedica Laboratories USA Inc. | 5a7594ca-30be-4350-827f-ef745a2a7e18 | 2026-01-30 | Warnings, Adverse reactions | 213853 ANDA213853 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | NIVAGEN PHARMACEUTICALS, INC. | 7c58bf4a-4a92-4db8-89bc-4de1b5831efc | 2025-12-09 | Warnings, Adverse reactions | 213853 ANDA213853 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | 604a011e-6c64-4895-8f6e-d28f119c4c22 | 2025-10-02 | Warnings, Adverse reactions | 213853 ANDA213853 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 71cd9b85-4914-4b0b-97db-7aaf25983211 | 2025-01-31 | Warnings, Adverse reactions | 213853 ANDA213853 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | DirectRX | d076309f-313a-1c71-e053-2995a90a7bb7 | 2025-01-20 | Warnings, Adverse reactions | 213853 ANDA213853 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | f7e8c8d2-b74e-6afd-e053-6394a90af83e | 2024-02-05 | Warnings, Adverse reactions | 213853 ANDA213853 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | Proficient Rx LP | acbbd2c4-60bd-4e01-ad7a-b9b3178569f0 | 2024-01-01 | Warnings, Adverse reactions | 213853 ANDA213853 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68788-8298-9 | 68788829809 | 90 TABLET in 1 BOTTLE (68788-8298-9) | 90 tablet | 2022-11-29 | 0000-00-00 | No | No | Current |