Enalapril Maleate and Hydrochlorothiazide
- Product NDC
- 51672-4045
- 11-digit product format
- 516724045
- Labeler code
- 51672
- Product ID
- 51672-4045_1130a62d-94e3-2dc6-e063-6394a90a8a67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Enalapril Maleate and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Taro Pharmaceuticals U.S.A., Inc.
- Application
- ANDA075788
- Marketing category
- ANDA
- Marketing start
- 2001-09-18
- Substance
- ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
- Active strength
- 5; 12.5 mg/1; mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- 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 |
|---|---|---|---|---|---|---|---|
| A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | |
| A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075788-001 | AB |
| A075788-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075788-001 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET / ORAL | AB | 2001-09-18 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075788-002 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET / ORAL | AB | 2001-09-18 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075788-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075788-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075788-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075788-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075788-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075788-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075788-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075788-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075788-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075788-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075788-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075788-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075788-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075788-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075788-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075788-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075788-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075788-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075788-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075788-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075788-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075788-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075788-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075788-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075788-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075788-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075788-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075788-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075788-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075788-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075788-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075788-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075788-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075788-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075788-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075788-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075788-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075788-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075788-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075788-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Enalapril Maleate and Hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ENALAPRIL MALEATE | 5 mg/1 |
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0J48LPH2TH | Internal UNII lookup |
| 9O25354EPJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7cb92cf2-46f2-4379-937c-168d230e43a4 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51672-4045-1 | Enalapril Maleate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | 12 | |
| 51672-4045-3 | Enalapril Maleate and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-4045-1 | EA - Each | 51672-4045 | 65069710-3c5b-4339-ba87-09ceb26cf720 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51672-4045 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240509_7cb92cf2-46f2-4379-937c-168d230e43a4.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 |
|---|---|---|---|---|---|---|
| Enalapril Maleate and Hydrochlorothiazide | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | Sun Pharmaceutical Industries, Inc. | 7cb92cf2-46f2-4379-937c-168d230e43a4 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 075788 ANDA075788 51672-4045 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 858828 | enalapril maleate 10 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 7cb92cf2-46f2-4379-937c-168d230e43a4 | 12 |
| 858824 | enalapril maleate 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 7cb92cf2-46f2-4379-937c-168d230e43a4 | 12 |
| 858828 | enalapril maleate 10 MG / hydrochlorothiazide 25 MG Oral Tablet | SCD | 7cb92cf2-46f2-4379-937c-168d230e43a4 | 12 |
| 858824 | enalapril maleate 5 MG / hydrochlorothiazide 12.5 MG Oral Tablet | SCD | 7cb92cf2-46f2-4379-937c-168d230e43a4 | 12 |
| 858828 | enalapril maleate 10 MG / HCTZ 25 MG Oral Tablet | SY | 7cb92cf2-46f2-4379-937c-168d230e43a4 | 12 |
| 858824 | enalapril maleate 5 MG / HCTZ 12.5 MG Oral Tablet | SY | 7cb92cf2-46f2-4379-937c-168d230e43a4 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51672-4045-1 | 51672404501 | 100 TABLET in 1 BOTTLE (51672-4045-1) | 100 tablet | 2001-09-18 | 0000-00-00 | No | No | Current |
| 51672-4045-3 | 51672404503 | 1000 TABLET in 1 BOTTLE (51672-4045-3) | 1000 tablet | 2001-09-18 | 0000-00-00 | No | No | Current |