Amlodipine and Benazepril Hydrochloride
- Product NDC
- 65862-582
- Requested package NDC
- 65862-582-22
- 11-digit product format
- 658620582
- Labeler code
- 65862
- Product ID
- 65862-582_a45ec3e8-1d14-4c27-9685-976323df8cad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and Benazepril Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202239
- Marketing category
- ANDA
- Marketing start
- 2012-09-05
- Substance
- AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
- Active strength
- 2.5; 10 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
- 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 |
|---|---|---|---|---|---|---|---|
| unfinished package | package | 65862-582 | 65862-582-22 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-10 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | |
| A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | |
| A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | |
| A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | |
| A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | |
| A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202239-001 | AB |
| A202239-002 | AB |
| A202239-003 | AB |
| A202239-004 | AB |
| A202239-005 | AB |
| A202239-006 | 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 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 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 | A202239-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-004 | AB | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine and Benazepril Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 2.5 mg/1 |
| BENAZEPRIL HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| N1SN99T69T | Internal UNII lookup |
| 864V2Q084H | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-582-01 | Amlodipine and Benazepril Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | 14 | |
| 65862-582-05 | Amlodipine and Benazepril Hydrochloride | 500 in 1 BOTTLE | CAPSULE | 500 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-582-01 | EA - Each | 65862-582 | cf65aff5-2d9f-4ed1-96cc-01e74e1369dc | 1 | 2013-02-13 |
| 65862-582-05 | EA - Each | 65862-582 | b22e0e01-f496-4dd9-91e6-4c667080d8fe | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | AvKARE | fe91d607-5e1f-48e4-e053-6294a90ac522 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | b25681a9-7b0e-40f9-844e-ec4842e3713c | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | REMEDYREPACK INC. | cb87f119-1598-405f-b627-eec749c8d42c | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | f2b56630-4e3a-6f9c-e053-2a95a90a4650 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 02e233c4-48d1-456d-8fc8-f99a06ef854a | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7b5eb6bd-e953-429e-9280-07da4f7d7f47 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 1dd12925-ede8-4ad5-9309-d8c79da1cebf | 2025-02-19 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719 | 2025-01-17 | Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | b6eb5283-8e07-47b8-b440-fe72859d8bcc | 2024-10-22 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 03b175fc-d430-490d-b7ac-9f7a2cb1dd8b | 2024-08-31 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 3de54c49-3590-4a70-9268-fa68e434d923 | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 30c401b5-decf-4c0c-8180-92a9b3d7d0fb | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | c870013c-e823-4233-a803-33a74f3610a8 | 2024-06-28 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Aurobindo Pharma Limited | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 65862-582 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 55bfd9ea-b474-4863-8fae-1b720d91034c | 2024-01-07 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 89d8d490-3a9c-40f2-86b7-94b5101dd09a | 2023-10-26 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | f77db79c-c998-4b63-9984-4cf245f188a7 | 2023-09-10 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 69a887ab-95cd-4b81-80ee-02e20eebf65b | 2023-08-24 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Proficient Rx LP | 29a0d87e-6afb-4766-9045-1963c5b0d183 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 898342 | amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral Capsule | PSN | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898346 | amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral Capsule | PSN | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898350 | amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral Capsule | PSN | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898353 | amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral Capsule | PSN | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898356 | amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral Capsule | PSN | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898359 | amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral Capsule | PSN | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898342 | amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule | SCD | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898346 | amlodipine 10 MG / benazepril hydrochloride 40 MG Oral Capsule | SCD | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898350 | amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral Capsule | SCD | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898353 | amlodipine 5 MG / benazepril hydrochloride 10 MG Oral Capsule | SCD | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898356 | amlodipine 5 MG / benazepril hydrochloride 20 MG Oral Capsule | SCD | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898359 | amlodipine 5 MG / benazepril hydrochloride 40 MG Oral Capsule | SCD | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898346 | amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898342 | amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898350 | amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898353 | amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898356 | amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898359 | amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898342 | Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898346 | Amlodipine 10 MG / BZP hydrochloride 40 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898350 | Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898353 | Amlodipine 5 MG / BZP hydrochloride 10 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898356 | Amlodipine 5 MG / BZP hydrochloride 20 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898359 | Amlodipine 5 MG / BZP hydrochloride 40 MG Oral Capsule | SY | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 14 |
| 898350 | amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral Capsule | PSN | da84991d-042f-473c-be9e-875e19ece2da | 3 |
| 898350 | amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral Capsule | SCD | da84991d-042f-473c-be9e-875e19ece2da | 3 |
| 898350 | amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral Capsule | SY | da84991d-042f-473c-be9e-875e19ece2da | 3 |
| 898350 | Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral Capsule | SY | da84991d-042f-473c-be9e-875e19ece2da | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Status |
|---|---|---|---|---|---|
| 65862-582-22 | 65862058222 | 2000 CAPSULE in 1 BAG (65862-582-22) | 2000 capsule | 05-SEP-12 | Current |