Atorvastatin Calcium
- Product NDC
- 68071-2687
- 11-digit product format
- 680712687
- Labeler code
- 68071
- Product ID
- 68071-2687_2a33cde3-24e8-d6da-e063-6394a90a85ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA076477
- Marketing category
- ANDA
- Marketing start
- 2011-12-01
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- 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
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 | 68071-2687 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 68071-2687 | 68071-2687-9 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076477-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2011-11-30 | ||
| A076477-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2011-11-30 | ||
| A076477-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2011-11-30 | ||
| A076477-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2011-11-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2011-11-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2011-11-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2011-11-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2011-11-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2011-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2011-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2011-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2011-11-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2011-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2011-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2011-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2011-11-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2011-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2011-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2011-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2011-11-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2011-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2011-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2011-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2011-11-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2011-11-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2011-11-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2011-11-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2011-11-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2011-11-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2011-11-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2011-11-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2011-11-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2011-11-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2011-11-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2011-11-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2011-11-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2011-11-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2011-11-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2011-11-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2011-11-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2011-11-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2011-11-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2011-11-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2011-11-30 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076477-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076477-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076477-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076477-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076477-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076477-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076477-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076477-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076477-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076477-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076477-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076477-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076477-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076477-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076477-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076477-004 | AB | 1 | 1e350fbaab3a… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa898d56-9495-d6f0-309b-68a5d8e3914a | Product name | 4 | 20260305 |
| d25cba4b-d79e-4890-8837-1382f7d09489 | Product name | 1 | 20231002 |
| 91774e91-b249-45e3-8ff8-4b5db2927a69 | Product name | 1 | 20230718 |
| 03fb3cda-d60a-4873-94e9-6fa77cfb1a1c | Product name | 1 | 20220302 |
| 34152997-af0b-acf4-dcaf-37211afe8ca4 | Product name | 9 | 20210312 |
| 46fdf265-6d5a-1bfb-93db-d82a4ea8aa81 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2687-9 | Atorvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2687 | ATORVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20241228_de45a760-4441-182e-e053-2995a90a2ffe.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 | Bryant Ranch Prepack | 2e583569-499d-4f20-87ca-84e7d9868d22 | 2026-07-14 | Warnings, Adverse reactions | 076477 ANDA076477 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Sun Pharmaceutical Industries Inc. | 595ab888-6b55-4642-a32f-e8521821ed81 | 2026-06-04 | Warnings, Adverse reactions | 076477 ANDA076477 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals, Inc. | 49dcc58a-9f23-045d-e063-6394a90abda6 | 2026-02-02 | Warnings, Adverse reactions | 076477 ANDA076477 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | DIRECT RX | c3b70f79-45a3-0869-e053-2a95a90a3cdb | 2025-01-20 | Warnings, Adverse reactions | 076477 ANDA076477 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | f7af3b3a-b73e-41ee-80e3-2be036672bb7 | 2024-08-22 | Warnings, Adverse reactions | 076477 ANDA076477 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | b1a840cf-47aa-b931-e053-2a95a90a1047 | 2024-07-17 | Warnings, Adverse reactions | 076477 ANDA076477 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | bbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f | 2024-05-30 | Warnings, Adverse reactions | 076477 ANDA076477 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Proficient Rx LP | d77e155c-403d-449e-bafd-11c9bd4974dd | 2020-01-01 | Warnings, Adverse reactions | 076477 ANDA076477 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617310 | atorvastatin calcium 20 MG Oral Tablet | PSN | de45a760-4441-182e-e053-2995a90a2ffe | 2 |
| 617310 | atorvastatin 20 MG Oral Tablet | SCD | de45a760-4441-182e-e053-2995a90a2ffe | 2 |
| 617310 | atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet | SY | de45a760-4441-182e-e053-2995a90a2ffe | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-2687-9 | 68071268709 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-2687-9) | 2022-05-05 | 0000-00-00 | No | No | Current |