Benazepril Hydrochloride
- Product NDC
- 68071-5129
- 11-digit product format
- 680715129
- Labeler code
- 68071
- Product ID
- 68071-5129_1b548daa-114c-398e-e063-6294a90a5b08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benazepril Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA076118
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Substance
- BENAZEPRIL HYDROCHLORIDE
- Active strength
- 10 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
- 2026-12-31
- 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 |
|---|---|---|---|---|---|
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68071-5129-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68071-5129-1 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68071-5129-1 | 1332a3947898… | d4bfe170f9cd… |
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.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benazepril Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENAZEPRIL HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| N1SN99T69T | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 898687 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 99755c59-18b9-ab7b-e053-2a95a90a4155 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a4484670-2869-6416-f6ff-03b1b3cbd1b0 | Product name | 2 | 20190415 |
| 55bffd21-17e1-ff02-2e8f-1f9a532b9502 | Product name | 2 | 20150320 |
| 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 |
|---|---|---|---|---|---|---|
| 68071-5129-1 | Benazepril Hydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-5129 | BENAZEPRIL HYDROCHLORIDE TABLET, COATED [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240621_99755c59-18b9-ab7b-e053-2a95a90a4155.zip |
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 68071-5129 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 898687 | benazepril HCl 10 MG Oral Tablet | PSN | 99755c59-18b9-ab7b-e053-2a95a90a4155 | 3 |
| 898687 | benazepril hydrochloride 10 MG Oral Tablet | SCD | 99755c59-18b9-ab7b-e053-2a95a90a4155 | 3 |
| 898687 | BZP hydrochloride 10 MG Oral Tablet | SY | 99755c59-18b9-ab7b-e053-2a95a90a4155 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-5129-1 | 68071512901 | 100 TABLET, COATED in 1 BOTTLE (68071-5129-1) | 2019-12-11 | 0000-00-00 | No | No | Current |