ATORVASTATIN CALCIUM
- Product NDC
- 67046-334
- 11-digit product format
- 670460334
- Labeler code
- 67046
- Product ID
- 67046-334_9ff4c5eb-7104-aa89-e053-2a95a90aa3a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler Enterprises
- Application
- ANDA205519
- Marketing category
- ANDA
- Marketing start
- 2020-01-15
- Marketing end
- 0000-00-00
- 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
- 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 product | product | 67046-334 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 67046-334 | 67046-334-30 | I | Inactivated by FDA | 2026-10-05 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 67046-334-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 67046-334-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 67046-334-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 67046-334-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 67046-334-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 67046-334-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 67046-334-30 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 67046-334-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 67046-334-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 67046-334-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 67046-334-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 67046-334-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 67046-334-30 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 67046-334-30 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 67046-334-30 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 67046-334-30 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 67046-334-30 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 67046-334-30 | bd6a592717d7… | 303034d00443… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205519-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | |
| A205519-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | |
| A205519-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | |
| A205519-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205519-001 | AB |
| A205519-002 | AB |
| A205519-003 | AB |
| A205519-004 | 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 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 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 | A205519-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205519-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205519-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205519-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A205519-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205519-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205519-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205519-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa898d56-9495-d6f0-309b-68a5d8e3914a | Product name | 4 | 20260305 |
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| d25cba4b-d79e-4890-8837-1382f7d09489 | Product name | 1 | 20231002 |
| 91774e91-b249-45e3-8ff8-4b5db2927a69 | Product name | 1 | 20230718 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 03fb3cda-d60a-4873-94e9-6fa77cfb1a1c | Product name | 1 | 20220302 |
| 34152997-af0b-acf4-dcaf-37211afe8ca4 | Product name | 9 | 20210312 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 46fdf265-6d5a-1bfb-93db-d82a4ea8aa81 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67046-334-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6db1-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use atorvastatin calcium safely and effectively. See full prescribing information for atorvastatin calcium tablets. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67046-334-30 | ATORVASTATIN CALCIUM | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 1 |
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 | ScieGen Pharmaceuticals, Inc. | f2d8b5e9-6ff2-4efa-ab01-e13df29f7371 | 2026-08-07 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Radha Pharmaceuticals, Inc. | 10e766cc-c3fd-4584-a0d7-652c516e828c | 2026-05-07 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | d1b9e56b-1632-4450-b1ca-d8bcbba3fd7c | 2026-03-02 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | e873d38c-4bda-4101-be98-85b1601d09f7 | 2026-02-18 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 1914264b-4c95-4066-91ca-b5c91d8b741e | 2026-02-18 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 5b9a5a36-7814-4d19-b146-01e819676ae2 | 2026-02-18 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Coupler LLC | 47cd0227-90a5-cdf6-e063-6294a90af661 | 2026-01-07 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 44a39b5a-77b6-42e8-9319-df21d3678e02 | 2025-11-12 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 635addf1-2024-4675-8d3c-380dc4548fbd | 2025-11-11 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 66df5c0b-be89-4fc7-8f8d-c7689952c662 | 2025-11-11 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 271409d0-5500-4ed0-8730-5a93226a2191 | 2025-11-11 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals, Inc. | 51f23212-a10d-4cfa-e054-00144ff88e88 | 2025-02-04 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | 3dbeae00-89ab-48a6-9e57-8048facb2294 | 2023-10-25 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Proficient Rx LP | a34d3c72-ce91-47c7-86a1-f32caaed2c47 | 2022-10-01 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ed8e76a5-6b40-47fe-9018-25bfe690a4dd | 2018-10-18 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cipla USA Inc., | 18fe5990-399d-416c-852f-e14974317b8b | 2018-03-13 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | b16b3805-7e60-447c-b3df-7a9392b63c99 | 2018-02-20 | Warnings, Adverse reactions | 205519 ANDA205519 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617310 | atorvastatin calcium 20 MG Oral Tablet | PSN | 9ff4c5eb-7103-aa89-e053-2a95a90aa3a4 | 1 |
| 617310 | atorvastatin 20 MG Oral Tablet | SCD | 9ff4c5eb-7103-aa89-e053-2a95a90aa3a4 | 1 |
| 617310 | atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet | SY | 9ff4c5eb-7103-aa89-e053-2a95a90aa3a4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67046-334-30 | 67046033430 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-334-30) | 2020-01-15 | 0000-00-00 | No | No | Current |