Atorvastatin calcium
- Product NDC
- 60760-979
- 11-digit product format
- 607600979
- Labeler code
- 60760
- Product ID
- 60760-979_cadd40b0-18a7-a176-e053-2a95a90ae2fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- St Mary's Medical Park Pharmacy
- Application
- ANDA211933
- Marketing category
- ANDA
- Marketing start
- 2021-08-30
- Marketing end
- 0000-00-00
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 60760-979 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 60760-979 | 60760-979-30 | D | Discontinued by firm | 2026-10-05 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211933-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-02-08 | |
| A211933-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-02-08 | |
| A211933-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-02-08 | |
| A211933-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2019-02-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211933-001 | AB |
| A211933-002 | AB |
| A211933-003 | AB |
| A211933-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211933-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-02-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211933-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-02-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211933-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-02-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211933-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2019-02-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A211933-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-02-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211933-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-02-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211933-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-02-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211933-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2019-02-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211933-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-02-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211933-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-02-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211933-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-02-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211933-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2019-02-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211933-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-02-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211933-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-02-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211933-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-02-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211933-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2019-02-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211933-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-02-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211933-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-02-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211933-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-02-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211933-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2019-02-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211933-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-02-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211933-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-02-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211933-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-02-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211933-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2019-02-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211933-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-02-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211933-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-02-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211933-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-02-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211933-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2019-02-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211933-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-02-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211933-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-02-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211933-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-02-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211933-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2019-02-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211933-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-02-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211933-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-02-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211933-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-02-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211933-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2019-02-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211933-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-02-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211933-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-02-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211933-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-02-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211933-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2019-02-08 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211933-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211933-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211933-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211933-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A211933-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211933-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211933-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211933-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211933-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211933-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211933-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211933-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211933-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211933-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211933-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211933-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211933-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211933-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211933-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211933-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211933-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211933-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211933-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211933-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211933-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211933-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211933-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211933-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211933-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211933-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211933-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211933-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211933-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211933-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211933-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211933-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211933-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211933-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211933-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211933-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-979-30 | EA - Each | 60760-979 | b2cf18f6-cf91-4aa5-92eb-184af7057b59 | 1 | 2021-11-09 |
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 |
|---|---|---|---|---|---|---|
| Atorvastatin calcium | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | 8d5b85cf-d8a0-e4d7-e053-2a95a90aad67 | 2024-06-18 | Warnings, Adverse reactions | 211933 ANDA211933 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | Novadoz Pharmaceuticals LLC | bc448f40-421c-490f-8c39-fa8135507973 | 2024-06-13 | Warnings, Adverse reactions | 211933 ANDA211933 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | A-S Medication Solutions | 498ef8e6-3366-42f4-99fe-b3e1dedae887 | 2023-12-27 | Warnings, Adverse reactions | 211933 ANDA211933 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | A-S Medication Solutions | d97df6ad-87ca-46ec-8de7-4a958ab3b463 | 2023-11-24 | Warnings, Adverse reactions | 211933 ANDA211933 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | A-S Medication Solutions | 01eadde8-37f3-4474-995f-22c1a65adf12 | 2023-04-07 | Warnings, Adverse reactions | 211933 ANDA211933 |
| Atorvastatin calcium | ATORVASTATIN CALCIUM | Proficient Rx LP | 514fcba1-713c-4aeb-be8c-369fcf9b4ffe | 2023-02-01 | Warnings, Adverse reactions | 211933 ANDA211933 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60760-979-30 | 60760097930 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-979-30) | 2021-08-30 | 0000-00-00 | No | No | Current |