Lisinopril
- Product NDC
- 63629-8079
- Requested package NDC
- 63629-8079-2
- 11-digit product format
- 636298079
- Labeler code
- 63629
- Product ID
- 63629-8079_b84e2360-15e6-4555-8d5d-c24d53f58b7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lisinopril
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076059
- Marketing category
- ANDA
- Marketing start
- 2002-07-01
- Marketing end
- 0000-00-00
- Substance
- LISINOPRIL
- Active strength
- 10 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
- 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 package | package | 63629-8079 | 63629-8079-2 | D | Discontinued by firm | 2026-08-17 |
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 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076059-001 | LISINOPRIL | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076059-002 | LISINOPRIL | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076059-003 | LISINOPRIL | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076059-004 | LISINOPRIL | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076059-005 | LISINOPRIL | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076059-006 | LISINOPRIL | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076059-001 | AB |
| A076059-002 | AB |
| A076059-003 | AB |
| A076059-004 | AB |
| A076059-005 | AB |
| A076059-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076059-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076059-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076059-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076059-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076059-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076059-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076059-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076059-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076059-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076059-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076059-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076059-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076059-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076059-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076059-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076059-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076059-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076059-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076059-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076059-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076059-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076059-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076059-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076059-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076059-004 | AB | 1 | 03ed91905a0d… |
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 |
|---|---|---|---|---|---|---|
| Lisinopril | LISINOPRIL | QPharma Inc | b17cd16b-8d0a-4cfa-bd48-2529983fcd12 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 076059 ANDA076059 |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 964c7f28-f62e-30b5-e053-2a95a90ab84c | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | 076059 ANDA076059 |
| Lisinopril | LISINOPRIL | Bryant Ranch Prepack | 33ebf3f2-cd71-4d8b-ac22-1a20a068a13d | 2024-10-07 | Boxed warning, Warnings, Adverse reactions | 076059 ANDA076059 |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | ab9bc1b4-60cc-76ea-e053-2995a90ac203 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 076059 ANDA076059 |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 90a589a9-acc2-bfbe-e053-2995a90a0bd2 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 076059 ANDA076059 |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 95376981-4620-c9aa-e053-2995a90a1390 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 076059 ANDA076059 |
| Lisinopril | LISINOPRIL | Bryant Ranch Prepack | 3783ab4c-2bed-414e-8927-62d47e3e3496 | 2024-01-15 | Boxed warning, Warnings, Adverse reactions | 076059 ANDA076059 |
| Lisinopril | LISINOPRIL | Bryant Ranch Prepack | 5af2444f-438c-4ea6-96e8-3dba1af9e1a5 | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | 076059 ANDA076059 |
| Lisinopril | LISINOPRIL | Proficient Rx LP | 8a14eaa6-cb8b-4088-ba15-840b587ab1f7 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 076059 ANDA076059 |
| Lisinopril | LISINOPRIL | Proficient Rx LP | 55a57d80-6bed-44a3-b3ea-6bb44c34cbfc | 2021-12-01 | Boxed warning, Warnings, Adverse reactions | 076059 ANDA076059 |
| Lisinopril | LISINOPRIL | Actavis Pharma, Inc. | 43e2c8d1-3704-4323-bcaf-f582572b81f7 | 2017-11-11 | Boxed warning, Warnings, Adverse reactions | 076059 ANDA076059 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-8079-2 | 63629807902 | 30 TABLET in 1 BOTTLE (63629-8079-2) | 30 tablet | 2019-07-18 | 0000-00-00 | No | No | Current |