LISINOPRIL
- Product NDC
- 67046-2097
- 11-digit product format
- 670462097
- Labeler code
- 67046
- Product ID
- 67046-2097_5605136e-588c-b597-e063-6394a90a2bfa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lisinopril
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA076164
- Marketing category
- ANDA
- Marketing start
- 2026-07-07
- Substance
- LISINOPRIL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076164-001 | LISINOPRIL | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076164-002 | LISINOPRIL | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076164-003 | LISINOPRIL | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076164-004 | LISINOPRIL | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076164-005 | LISINOPRIL | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076164-006 | LISINOPRIL | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076164-001 | AB |
| A076164-002 | AB |
| A076164-003 | AB |
| A076164-004 | AB |
| A076164-005 | AB |
| A076164-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-005 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-006 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-001 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-002 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-003 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-004 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076164-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076164-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076164-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076164-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076164-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076164-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076164-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076164-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076164-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076164-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076164-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076164-004 | AB | 1 | b8a1b40f171c… |
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
- LISINOPRIL
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LISINOPRIL | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| E7199S1YWR | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 311354 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 560513ef-4d2c-8ca0-e063-6394a90a674a | Available on FDA.report |
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 | REMEDYREPACK INC. | 12d6fe7e-b5a2-4d49-9a06-a6150234d061 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Coupler LLC | 560513ef-4d2c-8ca0-e063-6394a90a674a | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 67046-2097 |
| LISINOPRIL | LISINOPRIL | REMEDYREPACK INC. | e17bcc2e-f5ed-4846-95d3-a5479c7fee8d | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | St. Mary's Medical Park Pharmacy | 5f4c1a62-fb84-8cdc-e053-2a91aa0a671a | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | St. Mary's Medical Park Pharmacy | 5eff766f-82e2-4cd6-e053-2a91aa0a4782 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 4b6dc0d4-4acd-3606-e054-00144ff8d46c | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals Inc. | ab561d21-7466-4d8b-8d06-291c1d4d82ff | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Preferred Pharmaceuticals Inc. | 02c23f9c-f3cf-4366-ae1e-56296f1fedf9 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | f57bd658-05d8-475a-ae74-87d2c7866417 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | 176c744a-d4e3-4a4b-ac62-4fbcb1d8d7bf | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | bd804d65-742a-4890-ac9d-bee69968387d | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | 11a83bbc-9871-4df8-b3f2-7aba5149f3fe | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | eddec313-910c-4bf1-9095-2153db53bc6e | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | 350c6fc9-9774-4d49-9242-19e96944f83b | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | d18f2117-0d2a-4e0d-8ffb-130ca6900364 | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | RedPharm Drug, Inc. | 4f08cfc9-7afc-33aa-e054-00144ff88e88 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Northwind Health Company, LLC | ab2f8ab5-3c87-484a-e053-2995a90a42bb | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Northwind Health Company, LLC | ae2cdf9b-e71e-8315-e053-2995a90a5310 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Northwind Health Company, LLC | dac0c8f1-e3cf-11e6-e053-2a95a90adbcb | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
| LISINOPRIL | LISINOPRIL | Northwind Health Company, LLC | ae2d9df4-29ce-3d07-e053-2995a90ab184 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076164 ANDA076164 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67046-2097-3 | 67046209703 | 30 TABLET in 1 BLISTER PACK (67046-2097-3) | 30 tablet | 2026-07-07 | No | No | Current |