Amlodipine Besylate and Benazepril Hydrochloride
- Product NDC
- 70518-2566
- 11-digit product format
- 705182566
- Labeler code
- 70518
- Product ID
- 70518-2566_4a67fe46-26b2-1d6d-e063-6394a90aac21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate and Benazepril Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078466
- Marketing category
- ANDA
- Marketing start
- 2020-02-04
- Substance
- AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
- Active strength
- 10; 20 mg/1; mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|
| 2025-04-01 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 | 70518-2566-0 | 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 | 70518-2566-0 | 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 | 70518-2566-0 | 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 | 70518-2566-0 | 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 | 70518-2566-0 | 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 | 70518-2566-0 | 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 | 70518-2566-0 | 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 | 70518-2566-0 | 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 | 70518-2566-0 | 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 | 70518-2566-0 | 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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine Besylate and Benazepril Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 10 mg/1 |
| BENAZEPRIL HYDROCHLORIDE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 864V2Q084H | Internal UNII lookup |
| N1SN99T69T | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 898342 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ea774c36-e970-4d9c-9487-6cc57741fec5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa898d56-9495-d6f0-309b-68a5d8e3914a | Product name | 4 | 20260305 |
| c19ec24d-2c40-4b8d-7c20-500ffa3660a1 | Product name | 3 | 20260303 |
| b15e9aa6-d523-ca97-480e-570e0543a342 | Product name | 4 | 20251024 |
| 265792b3-b999-c010-7364-a7db20b9d4d9 | Product name | 5 | 20250515 |
| 14c2c15b-f823-4ada-a40e-a440544294dc | Product name | 1 | 20221207 |
| a72887ef-d675-499f-af4b-78688f6855cd | Product name | 1 | 20191002 |
| a4484670-2869-6416-f6ff-03b1b3cbd1b0 | Product name | 2 | 20190415 |
| 4a27501f-a987-48a5-99b4-e983d4744d76 | Product name | 7 | 20181211 |
| 18600d07-613d-bf9c-2711-fe40c06f3393 | Product name | 5 | 20180703 |
| bded1554-44de-900a-5297-403365d6d4b2 | Product name | 3 | 20170110 |
| 55bffd21-17e1-ff02-2e8f-1f9a532b9502 | Product name | 2 | 20150320 |
| 1f1c6e4b-bbad-4649-afd1-7a1d671db4b1 | Product name | 1 | 20150316 |
| 63ab5fbf-2a6b-c41d-051a-39e845d718b1 | Product name | 1 | 20140508 |
| 7613b1a5-acb6-4e5e-6048-c44deeeb1212 | Product name | 1 | 20140508 |
| b9fbc696-7d55-c52e-4f12-7e3d99cd2db4 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-2566-0 | Amlodipine Besylate and Benazepril Hydrochloride | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70518-2566-0 | EA - Each | 70518-2566 | a7cb0f66-0d77-47cd-9499-f7aa55938d49 | 1 | 2026-01-08 |
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 70518-2566 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 898342 | amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral Capsule | PSN | ea774c36-e970-4d9c-9487-6cc57741fec5 | 10 |
| 898342 | amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule | SCD | ea774c36-e970-4d9c-9487-6cc57741fec5 | 10 |
| 898342 | amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral Capsule | SY | ea774c36-e970-4d9c-9487-6cc57741fec5 | 10 |
| 898342 | Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule | SY | ea774c36-e970-4d9c-9487-6cc57741fec5 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2566-0 | 70518256600 | 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-2566-0) | 90 capsule | 2020-02-04 | 0000-00-00 | No | No | Current |