Lisinopril
- Product NDC
- 31722-180
- 11-digit product format
- 317220180
- Labeler code
- 31722
- Product ID
- 31722-180_337644b9-adae-41c1-9a9c-8d879ab355d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lisinopril
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA075903
- Marketing category
- ANDA
- Marketing start
- 2021-08-17
- Substance
- LISINOPRIL
- Active strength
- 40 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075903-001 | LISINOPRIL | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075903-002 | LISINOPRIL | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075903-003 | LISINOPRIL | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075903-004 | LISINOPRIL | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075903-005 | LISINOPRIL | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075903-006 | LISINOPRIL | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075903-001 | AB |
| A075903-002 | AB |
| A075903-003 | AB |
| A075903-004 | AB |
| A075903-005 | AB |
| A075903-006 | 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 | A075903-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075903-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075903-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075903-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075903-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075903-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075903-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075903-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075903-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075903-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075903-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075903-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-005 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-006 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075903-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075903-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075903-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075903-004 | LISINOPRIL | 20MG | 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 | A075903-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075903-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075903-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075903-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075903-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075903-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075903-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075903-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075903-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075903-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075903-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075903-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075903-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075903-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075903-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075903-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075903-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075903-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075903-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075903-004 | 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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LISINOPRIL | 40 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| E7199S1YWR | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 387068e7-7fb9-44f3-ae1c-e45ebc755a3e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820 | Product name | 1 | 20230703 |
| f65307a7-3644-0a09-cdfd-94aae8d3b53e | Product name | 3 | 20210902 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d | Product name | 2 | 20170719 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 31722-180-01 | Lisinopril | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 31722-180-10 | Lisinopril | 1000 in 1 BOTTLE | TABLET | 1000 | 1 | |
| 31722-180-31 | Lisinopril | 71428 in 1 CARTON | TABLET | 71428 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 31722-180-01 | EA - Each | 31722-180 | 7286566d-3d37-4019-b563-ad7124087bd7 | 1 | 2022-08-04 |
| 31722-180-10 | EA - Each | 31722-180 | 38adf175-df8f-4141-9d89-8d62186dbe41 | 1 | 2022-08-04 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 31722-180 | LISINOPRIL (LISINOPRIL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20240830_387068e7-7fb9-44f3-ae1c-e45ebc755a3e.zip |
| 31722-180 | LISINOPRIL (LISINOPRIL) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20211104_8f20acd7-2635-4a9b-b732-2a84ea93dea7.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 |
|---|---|---|---|---|---|---|
| Lisinopril | LISINOPRIL | Legacy Pharmaceutical Packaging, LLC | f5db9549-e179-3db6-e053-2995a90a1544 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 075903 ANDA075903 |
| Lisinopril | LISINOPRIL | Camber Pharmaceuticals, Inc. | 387068e7-7fb9-44f3-ae1c-e45ebc755a3e | 2024-08-29 | Boxed warning, Warnings, Adverse reactions | 075903 ANDA075903 31722-180 |
| Lisinopril | LISINOPRIL | Camber Pharmaceuticals, Inc. | 8f20acd7-2635-4a9b-b732-2a84ea93dea7 | 2021-11-03 | Boxed warning, Warnings, Adverse reactions | 075903 ANDA075903 31722-180 |
| Lisinopril | LISINOPRIL | XLCare Pharmaceuticals Inc. | c008ecb6-970d-4ac9-9402-e21e8d9d76b2 | 2021-09-23 | Boxed warning, Warnings, Adverse reactions | 075903 ANDA075903 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 31722-180-01 | 31722018001 | 100 TABLET in 1 BOTTLE (31722-180-01) | 100 tablet | 2021-08-17 | 0000-00-00 | No | No | Current |
| 31722-180-10 | 31722018010 | 1000 TABLET in 1 BOTTLE (31722-180-10) | 1000 tablet | 2021-08-17 | 0000-00-00 | No | No | Current |
| 31722-180-31 | 31722018031 | 71428 TABLET in 1 CARTON (31722-180-31) | 71428 tablet | 2021-08-17 | No | No | Current |