Benazepril Hydrochloride
- Product NDC
- 60760-352
- 11-digit product format
- 607600352
- Labeler code
- 60760
- Product ID
- 60760-352_7a024766-f7af-7685-e053-2a91aa0ab774
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benazepril Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- St. Mary's Medical Park Pharmacy
- Application
- ANDA076118
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- BENAZEPRIL HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 60760-352 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 60760-352 | 60760-352-90 | D | Discontinued by firm | 2026-10-05 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076118-001 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | |
| A076118-002 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | |
| A076118-003 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | |
| A076118-004 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076118-001 | AB |
| A076118-002 | AB |
| A076118-003 | AB |
| A076118-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076118-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076118-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076118-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076118-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076118-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076118-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076118-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076118-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-352-90 | EA - Each | 60760-352 | 474863f8-c0fc-44d9-8217-beefe9693fde | 1 | 2017-12-14 |
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 |
|---|---|---|---|---|---|---|
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 53fea330-cc4a-3b7e-e054-00144ff88e88 | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Proficient Rx LP | be41d21c-4747-47bb-b4b7-bbfabcd7a9b1 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Solco healthcare U.S., LLC | bb91223e-ffa5-4a3a-b191-fe121250c20c | 2024-06-30 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 99755c59-18b9-ab7b-e053-2a95a90a4155 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9987a842-07a5-635e-e053-2995a90afa32 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Proficient Rx LP | ebdf5144-752d-456f-b46d-19cbba0bc3d7 | 2024-01-01 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | b0d3122a-5332-4af6-98d8-520ed70ace62 | 2023-11-27 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Proficient Rx LP | 313225d7-f947-40b3-96d7-289aad300a4a | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60760-352-90 | 60760035290 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-352-90) | 2017-11-15 | 0000-00-00 | No | No | Current |