Lisinopril
- Product NDC
- 0615-8061
- 11-digit product format
- 006158061
- Labeler code
- 0615
- Product ID
- 0615-8061_4643015f-3f68-4ecd-909f-85e3fd2c8549
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lisinopril
- Dosage form
- TABLET
- Route
- ORAL; ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA076180
- Marketing category
- ANDA
- Marketing start
- 2011-11-01
- Marketing end
- 2020-09-30
- Substance
- LISINOPRIL
- Active strength
- 3 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
- 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 | 0615-8061 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 0615-8061 | 0615-8061-05 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 0615-8061 | 0615-8061-39 | D | Discontinued by firm | 2026-08-11 |
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 | 0615-8061-39 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0615-8061-05 | 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 | 0615-8061-39 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0615-8061-05 | 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 | 0615-8061-39 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0615-8061-05 | 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 | 0615-8061-39 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0615-8061-05 | 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 | 0615-8061-39 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0615-8061-05 | 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 | 0615-8061-39 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0615-8061-05 | 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 | 0615-8061-39 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0615-8061-05 | 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 | 0615-8061-39 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0615-8061-05 | 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 | 0615-8061-39 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0615-8061-05 | 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 | 0615-8061-39 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0615-8061-05 | 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 | 0615-8061-39 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0615-8061-05 | 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 | 0615-8061-39 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0615-8061-05 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076180-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076180-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076180-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 74a2ff9319b5… | |
| 2020-11-12 02:37 UTC | 2020-11 | A076180-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A076180-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A076180-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A076180-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | A076180-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | A076180-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A076180-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | A076180-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | A076180-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A076180-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | A076180-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | A076180-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | ea99ee380514… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076180-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076180-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076180-003 | AB | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | A076180-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076180-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076180-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076180-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076180-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076180-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076180-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076180-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076180-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076180-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076180-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076180-003 | AB | 1 | ea99ee380514… |
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 | St. Mary's Medical Park Pharmacy | 6051cc96-86e0-bd0b-e053-2a91aa0a5dcf | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | REMEDYREPACK INC. | 42f49299-7ae5-4d30-86eb-66b739c0e95d | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | St. Mary's Medical Park Pharmacy | 6062fd98-7663-f4b5-e053-2a91aa0acbc3 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals Inc. | 7e297133-669e-4780-a966-c777624e5427 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals Inc. | affd3e43-077e-42e5-a865-c961624bfe93 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals, Inc. | 74415f95-74c9-4329-a6af-a0f165bf7887 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | Quality Care Products LLC | babb75f0-bccc-44e8-955a-6873344ccc21 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 4f1f76fe-816c-384a-e054-00144ff88e88 | 2024-12-03 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 4aa518e1-d989-1fde-e054-00144ff88e88 | 2024-07-19 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 4aa44af9-1aff-314c-e054-00144ff8d46c | 2024-07-19 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 5a1c5b04-b78c-c057-e053-2991aa0aa916 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 9148529f-6278-e507-e053-2995a90aa4cf | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 86e7a336-c416-6fab-e053-2a91aa0a274c | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | e5fbefd1-4077-4e81-a0e3-e09fadc48593 | 2023-05-01 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | b5683ac4-59dc-4772-8bc6-984c698afbeb | 2023-02-04 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | Aphena Pharma Solutions - Tennessee, LLC | 2dbec080-a266-4317-8d4b-b4046206416e | 2022-02-22 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |
| LISINOPRIL | LISINOPRIL | Aphena Pharma Solutions - Tennessee, LLC | 6ba2c7d6-bc9e-4d8b-8d1e-c14004750693 | 2021-08-17 | Boxed warning, Warnings, Adverse reactions | 076180 ANDA076180 |