Amlodipine Besylate and Benazepril Hydrochloride
- Product NDC
- 43063-571
- 11-digit product format
- 430630571
- Labeler code
- 43063
- Product ID
- 43063-571_a033b7c9-7af3-9c74-e053-2a95a90ae8c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate and Benazepril Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078466
- Marketing category
- ANDA
- Marketing start
- 2010-02-05
- Marketing end
- 2020-03-31
- Substance
- AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 43063-571 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 43063-571 | 43063-571-90 | D | Discontinued by firm | 2026-08-03 |
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 | 43063-571-90 | 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 | 43063-571-90 | 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 | 43063-571-90 | 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 | 43063-571-90 | 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 | 43063-571-90 | 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 | 43063-571-90 | 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 | 43063-571-90 | 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 | 43063-571-90 | 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 | 43063-571-90 | 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 | 43063-571-90 | 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 | 43063-571-90 | 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 | 43063-571-90 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078466-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | |
| A078466-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | |
| A078466-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | |
| A078466-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | |
| A078466-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | |
| A078466-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | RS | 2011-07-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078466-001 | AB |
| A078466-002 | AB |
| A078466-003 | AB |
| A078466-004 | AB |
| A078466-005 | AB |
| A078466-006 | 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 | A078466-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078466-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078466-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078466-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078466-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078466-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2011-07-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078466-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078466-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2010-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078466-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078466-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2010-02-05 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078466-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078466-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078466-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078466-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078466-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078466-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078466-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078466-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078466-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078466-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078466-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078466-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078466-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078466-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078466-004 | AB | 1 | 2680178bc6a6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43063-571-90 | EA - Each | 43063-571 | 0c965326-fa27-4a30-b622-63dea80543aa | 1 | 2015-05-05 |
DailyMed Socrata Ingredients#
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 Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | c695f95d-6064-4a22-84ba-c8e62477b3a7 | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 318b3273-e8f7-416c-b371-10c56fa8e0fd | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5f7a4bd1-8083-46ca-95f2-e8c476b5367c | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ff807933-7433-4f8c-9d09-02a57e51d0fc | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | f16e04b5-57b9-49cc-811b-07d85ccb5d9f | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 4e6bf47a-ee8a-4083-8cce-a6a25260d3fb | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | REMEDYREPACK INC. | ea774c36-e970-4d9c-9487-6cc57741fec5 | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 5813e6b6-f524-4fba-99ba-9f4e365bf523 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | c56a384c-b250-4a43-99ce-ddd88376c817 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 3b13554a-0f63-4238-8f55-a1400c847c9f | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 2b0e3752-c54e-4c50-9640-1a6fefa6dec5 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 3ad66075-0875-4703-9d21-a424b5ab892a | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | c9693ad5-0fa6-4796-b20b-2021d589a132 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 968c611b-43a7-40f0-9ed3-aa67ee88364b | 2025-10-03 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | REMEDYREPACK INC. | dc206611-5188-40a6-b025-61db41f68a5a | 2025-07-07 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | REMEDYREPACK INC. | 0f253cac-67ac-4b03-b1a8-f2c345938dda | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | d058e426-8786-4fd3-a771-992e4558c135 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 7c75fa72-9b0f-44bf-a745-dfa647ed1e78 | 2025-01-15 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | BluePoint Laboratories | df8e23c8-6c8f-4293-8a37-5ad3d48dba94 | 2023-05-03 | Boxed warning, Warnings, Adverse reactions | 078466 ANDA078466 |