Enalapril Maleate
- Product NDC
- 60760-587
- 11-digit product format
- 607600587
- Labeler code
- 60760
- Product ID
- 60760-587_cdb65308-1fae-f3b3-e053-2995a90abad9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Enalapril Maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- St. Mary's Medical Park Pharmacy
- Application
- ANDA075657
- Marketing category
- ANDA
- Marketing start
- 2021-09-23
- Marketing end
- 0000-00-00
- Substance
- ENALAPRIL MALEATE
- Active strength
- 5 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
- 2022-12-31
- 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 product | product | 60760-587 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 60760-587 | 60760-587-30 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075657-001 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | |
| A075657-002 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | |
| A075657-003 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | |
| A075657-004 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075657-001 | AB |
| A075657-002 | AB |
| A075657-003 | AB |
| A075657-004 | 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 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075657-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075657-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075657-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075657-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-004 | AB | 1 | d8e5a09893c0… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-587-30 | EA - Each | 60760-587 | c92639d9-7a36-4e8c-acce-a260271e9cf2 | 1 | 2021-11-09 |
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 |
|---|---|---|---|---|---|---|
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | fb3c7066-76cb-4e8e-b98b-bcb41a3631df | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Sun Pharmaceutical Industries, Inc. | f103b9f9-e081-419d-a2d8-b86acda834dd | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | A-S Medication Solutions | bc875f91-d781-43a9-8f7e-e2cfc019ad3f | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Northwind Health Company, LLC | ab2ffb6e-4628-e44c-e053-2a95a90a2336 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | 3fbc6cce-7ad5-49d5-9705-5f66ef92d544 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Golden State Medical Supply, Inc. | 0a12343f-5733-40cc-93b4-a02f5147fb91 | 2025-01-13 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | bdb34c96-1532-4ce5-93a7-3cc90904c910 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 2061543d-67e7-46b6-aa56-cafa11ae4b93 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | A-S Medication Solutions | 0ad4bfb4-62db-4759-af60-88eb031d125a | 2023-12-12 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Golden State Medical Supply, Inc. | 074fe718-88d8-365c-e063-6394a90a299d | 2023-10-09 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | A-S Medication Solutions | f3754f29-9b75-4e2c-9c28-b3479f5bf906 | 2023-10-02 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | b4b7b936-4a62-4991-8d3c-03bb37f044c1 | 2023-10-02 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Proficient Rx LP | ca1d0143-bbd3-4041-9981-eadbb8893a2b | 2020-03-01 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60760-587-30 | 60760058730 | 30 TABLET in 1 BOTTLE, PLASTIC (60760-587-30) | 30 tablet | 2021-09-23 | 0000-00-00 | No | No | Current |