Amlodipine and atorvastatin
- Product NDC
- 0378-4510
- 11-digit product format
- 003784510
- Labeler code
- 0378
- Product ID
- 0378-4510_bd2370c0-0e67-4e93-b4cf-08134ba68346
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and atorvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA200465
- Marketing category
- ANDA
- Marketing start
- 2014-06-24
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 3 mg/1; mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 0378-4510 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 0378-4510 | 0378-4510-93 | D | Discontinued by firm | 2026-08-11 |
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 | 0378-4510-93 | 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 | 0378-4510-93 | 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 | 0378-4510-93 | 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 | 0378-4510-93 | 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 | 0378-4510-93 | 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 | 0378-4510-93 | 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 | 0378-4510-93 | 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 | 0378-4510-93 | 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 | 0378-4510-93 | 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 | 0378-4510-93 | 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 | 0378-4510-93 | 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 | 0378-4510-93 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A200465-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | 2013-11-29 | ||
| A200465-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | 2013-11-29 | ||
| A200465-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | 2013-11-29 | ||
| A200465-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | |
| A200465-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200465-004 | AB |
| A200465-005 | AB |
| A200465-006 | AB |
| A200465-007 | AB |
| A200465-008 | AB |
| A200465-009 | AB |
| A200465-010 | AB |
| A200465-011 | 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 | A200465-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | 2013-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200465-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | 2013-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200465-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | 2013-11-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200465-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | 2013-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | 2013-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | 2013-11-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | 2013-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200465-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | 2013-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200465-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | 2013-11-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200465-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-008 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-009 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-010 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-011 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-001 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | 2013-11-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-002 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | 2013-11-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-003 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | 2013-11-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-004 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | 2013-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-005 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | 2013-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-006 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | 2013-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-007 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | 2013-11-29 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A200465-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-008 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-009 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-010 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200465-011 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-008 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-009 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-010 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200465-011 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-008 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-009 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-010 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200465-011 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-008 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-009 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-010 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200465-011 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-007 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-008 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-009 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-010 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200465-011 | AB | 1 | b8a1b40f171c… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-4510-93 | EA - Each | 0378-4510 | 252212cb-9855-4efb-8f1f-27d1a97d1bf1 | 1 | 2014-07-02 |
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 |
|---|---|---|---|---|---|---|
| Amlodipine and atorvastatin | AMLODIPINE AND ATORVASTATIN | Mylan Pharmaceuticals Inc. | 4be76756-4114-4d50-a36c-fd410f6c773d | 2024-11-11 | Warnings, Adverse reactions | 200465 ANDA200465 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0378-4510-93 | 00378451093 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4510-93) | 2014-06-24 | 0000-00-00 | No | No | Current |