Amlodipine and Benazepril Hydrochloride
- Product NDC
- 0093-7670
- 11-digit product format
- 000937670
- Labeler code
- 0093
- Product ID
- 0093-7670_fae2ca85-de6d-424b-83f5-01680531f985
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and Benazepril Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA077179
- Marketing category
- ANDA
- Marketing start
- 2011-07-20
- Marketing end
- 2020-05-31
- 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 | 0093-7670 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 0093-7670 | 0093-7670-01 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0093-7670-01 | 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 | 0093-7670-01 | 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 | 0093-7670-01 | 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 | 0093-7670-01 | 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 | 0093-7670-01 | 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 | 0093-7670-01 | 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 | 0093-7670-01 | 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 | 0093-7670-01 | 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 | 0093-7670-01 | 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 | 0093-7670-01 | 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 | 0093-7670-01 | 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 | 0093-7670-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077179-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | ||
| A077179-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | ||
| A077179-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | ||
| A077179-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | ||
| A077179-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | ||
| A077179-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077179-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077179-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077179-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077179-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077179-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077179-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077179-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077179-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077179-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077179-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077179-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077179-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077179-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077179-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077179-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077179-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077179-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077179-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077179-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077179-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077179-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077179-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077179-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077179-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077179-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077179-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077179-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077179-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077179-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077179-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077179-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077179-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077179-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077179-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077179-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077179-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | 2011-07-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077179-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077179-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | 2007-05-18 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077179-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077179-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | 2007-05-18 | b8a1b40f171c… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa898d56-9495-d6f0-309b-68a5d8e3914a | Product name | 4 | 20260305 |
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-7670-01 | EA - Each | 0093-7670 | 8094fc27-63be-426c-b524-d68d03139a17 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 898359 | amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral Capsule | PSN | 180506ee-0d90-4399-bc7b-fb1489951551 | 1000 |
| 898359 | amlodipine 5 MG / benazepril hydrochloride 40 MG Oral Capsule | SCD | 180506ee-0d90-4399-bc7b-fb1489951551 | 1000 |
| 898359 | amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral Capsule | SY | 180506ee-0d90-4399-bc7b-fb1489951551 | 1000 |
| 898359 | Amlodipine 5 MG / BZP hydrochloride 40 MG Oral Capsule | SY | 180506ee-0d90-4399-bc7b-fb1489951551 | 1000 |