Vasotec
- Product NDC
- 0187-0143
- Requested package NDC
- 0187-0143-90
- 11-digit product format
- 001870143
- Labeler code
- 0187
- Product ID
- 0187-0143_1be6ec2b-1c20-4ff4-a8ff-cd23e3de9fa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Enalapril Maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bausch Health US LLC
- Application
- NDA018998
- Marketing category
- NDA
- Marketing start
- 1985-12-24
- Substance
- ENALAPRIL MALEATE
- Active strength
- 20 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
- 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 |
|---|---|---|---|---|---|---|---|
| N018998-001 | VASOTEC | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | RLD | 1985-12-24 |
| N018998-002 | VASOTEC | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | RLD | 1985-12-24 |
| N018998-003 | VASOTEC | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | RLD, RS | 1985-12-24 |
| N018998-005 | VASOTEC | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | RLD | 1988-07-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018998-001 | AB |
| N018998-002 | AB |
| N018998-003 | AB |
| N018998-005 | 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 | N018998-001 | VASOTEC | 5MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N018998-002 | VASOTEC | 10MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N018998-003 | VASOTEC | 20MG | TABLET / ORAL | AB | RLD, RS | 1985-12-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N018998-005 | VASOTEC | 2.5MG | TABLET / ORAL | AB | RLD | 1988-07-26 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N018998-001 | VASOTEC | 5MG | TABLET / ORAL | AB | RLD | 1985-12-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018998-002 | VASOTEC | 10MG | TABLET / ORAL | AB | RLD | 1985-12-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018998-003 | VASOTEC | 20MG | TABLET / ORAL | AB | RLD, RS | 1985-12-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018998-005 | VASOTEC | 2.5MG | TABLET / ORAL | AB | RLD | 1988-07-26 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018998-001 | VASOTEC | 5MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018998-002 | VASOTEC | 10MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018998-003 | VASOTEC | 20MG | TABLET / ORAL | AB | RLD, RS | 1985-12-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018998-005 | VASOTEC | 2.5MG | TABLET / ORAL | AB | RLD | 1988-07-26 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018998-001 | VASOTEC | 5MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018998-002 | VASOTEC | 10MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018998-003 | VASOTEC | 20MG | TABLET / ORAL | AB | RLD, RS | 1985-12-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018998-005 | VASOTEC | 2.5MG | TABLET / ORAL | AB | RLD | 1988-07-26 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018998-001 | VASOTEC | 5MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018998-002 | VASOTEC | 10MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018998-003 | VASOTEC | 20MG | TABLET / ORAL | AB | RLD, RS | 1985-12-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018998-005 | VASOTEC | 2.5MG | TABLET / ORAL | AB | RLD | 1988-07-26 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018998-001 | VASOTEC | 5MG | TABLET / ORAL | AB | RLD | 1985-12-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018998-002 | VASOTEC | 10MG | TABLET / ORAL | AB | RLD | 1985-12-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018998-003 | VASOTEC | 20MG | TABLET / ORAL | AB | RLD, RS | 1985-12-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018998-005 | VASOTEC | 2.5MG | TABLET / ORAL | AB | RLD | 1988-07-26 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018998-001 | VASOTEC | 5MG | TABLET / ORAL | AB | RLD | 1985-12-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018998-002 | VASOTEC | 10MG | TABLET / ORAL | AB | RLD | 1985-12-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018998-003 | VASOTEC | 20MG | TABLET / ORAL | AB | RLD, RS | 1985-12-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018998-005 | VASOTEC | 2.5MG | TABLET / ORAL | AB | RLD | 1988-07-26 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018998-001 | VASOTEC | 5MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018998-002 | VASOTEC | 10MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018998-003 | VASOTEC | 20MG | TABLET / ORAL | AB | RLD, RS | 1985-12-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018998-005 | VASOTEC | 2.5MG | TABLET / ORAL | AB | RLD | 1988-07-26 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018998-001 | VASOTEC | 5MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018998-002 | VASOTEC | 10MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018998-003 | VASOTEC | 20MG | TABLET / ORAL | AB | RLD, RS | 1985-12-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018998-005 | VASOTEC | 2.5MG | TABLET / ORAL | AB | RLD | 1988-07-26 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018998-001 | VASOTEC | 5MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018998-002 | VASOTEC | 10MG | TABLET / ORAL | AB | RLD | 1985-12-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018998-003 | VASOTEC | 20MG | TABLET / ORAL | AB | RLD, RS | 1985-12-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018998-005 | VASOTEC | 2.5MG | TABLET / ORAL | AB | RLD | 1988-07-26 | 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 | N018998-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N018998-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N018998-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N018998-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N018998-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018998-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018998-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018998-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018998-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018998-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018998-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018998-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018998-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018998-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018998-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018998-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018998-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018998-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018998-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018998-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018998-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018998-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018998-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018998-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018998-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018998-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018998-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018998-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018998-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018998-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018998-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018998-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018998-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018998-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018998-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018998-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018998-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018998-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018998-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018998-005 | 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
- Vasotec
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ENALAPRIL MALEATE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9O25354EPJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 39631f1f-5d19-43c1-b504-bf56d991ed97 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5ffbd585-373a-fcf5-c6c8-1f04bf28013e | Product name | 3 | 20250331 |
| 2c0b09af-323c-477d-9a19-d8165aefa3b0 | Product name | 4 | 20250107 |
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 628e4aea-ca7c-e8c4-6fcc-d791c4deb0ae | Product name | 1 | 20140508 |
| 78637fb0-95c8-441f-e4b4-db1274b6f956 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0187-0143-10 | Vasotec | 1000 in 1 BOTTLE | TABLET | 1000 | 15 | |
| 0187-0143-30 | Vasotec | 30 in 1 BOTTLE | TABLET | 30 | 15 | |
| 0187-0143-90 | Vasotec | 90 in 1 BOTTLE | TABLET | 90 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0187-0143-10 | EA - Each | 0187-0143 | 31320af4-76d4-4557-b8fb-ec4d0819e944 | 1 | 2013-03-03 |
| 0187-0143-30 | EA - Each | 0187-0143 | aefc26cd-c1ee-44ff-91e3-35b6ed1ffb9f | 1 | 2013-02-13 |
| 0187-0143-90 | EA - Each | 0187-0143 | 4abe8822-d3b4-4b6b-9ecc-cbb5bbeccc48 | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Vasotec | ENALAPRIL MALEATE | Bausch Health US LLC | 39631f1f-5d19-43c1-b504-bf56d991ed97 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 018998 NDA018998 0187-0143-90 0187-0143 00187014390 |
| Enalapril Maleate | ENALAPRIL MALEATE | OCEANSIDE PHARMACEUTICALS | ebd2a62d-a704-4f8a-a104-749a5296502f | 2020-12-01 | Boxed warning, Warnings, Adverse reactions | 018998 NDA018998 |
| Enalapril Maleate | ENALAPRIL MALEATE | Proficient Rx LP | cc921315-8da1-487c-ba19-433470f5c8d8 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 018998 NDA018998 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0187-0143-90 | 00187014390 | 90 TABLET in 1 BOTTLE (0187-0143-90) | 90 tablet | 1985-12-24 | 0000-00-00 | No | No | Current |