Enalapril Maleate
- Product NDC
- 43547-546
- 11-digit product format
- 435470546
- Labeler code
- 43547
- Product ID
- 43547-546_c3c8f70a-800d-40f1-8f11-0cc49c51d67c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Enalapril Maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA213273
- Marketing category
- ANDA
- Marketing start
- 2022-07-31
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Enalapril Maleate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ENALAPRIL MALEATE | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9O25354EPJ |
| Rxcui | 858804, 858810, 858813, 858817 |
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 |
|---|---|---|---|---|---|---|
| 43547-546-03 | Enalapril Maleate | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 43547-546-09 | Enalapril Maleate | 90 in 1 BOTTLE | TABLET | 90 | 3 | |
| 43547-546-10 | Enalapril Maleate | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 43547-546-11 | Enalapril Maleate | 1000 in 1 BOTTLE | TABLET | 1000 | 3 | |
| 43547-546-50 | Enalapril Maleate | 500 in 1 BOTTLE | TABLET | 500 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-546-10 | EA - Each | 43547-546 | 73f58c89-a669-4ff7-bc3b-64aba7721f20 | 1 | 2022-09-12 |
| 43547-546-11 | EA - Each | 43547-546 | 251a5ed1-e9a6-4430-9721-786cc6a1afc2 | 1 | 2022-09-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 858813 | enalapril maleate 5 MG Oral Tablet | PSN | 1b464099-491d-473b-836e-9d86b2b1eeec | 7 |
| 858813 | enalapril maleate 5 MG Oral Tablet | SCD | 1b464099-491d-473b-836e-9d86b2b1eeec | 7 |
| 858813 | enalapril maleate 5 MG Oral Tablet | PSN | 5596ba00-4a1c-4503-99db-3a9617ed17c0 | 4 |
| 858813 | enalapril maleate 5 MG Oral Tablet | SCD | 5596ba00-4a1c-4503-99db-3a9617ed17c0 | 4 |
| 858817 | enalapril maleate 10 MG Oral Tablet | PSN | 0c829189-fba2-48f8-a23f-d5471a0345f6 | 3 |
| 858804 | enalapril maleate 2.5 MG Oral Tablet | PSN | 0c829189-fba2-48f8-a23f-d5471a0345f6 | 3 |
| 858810 | enalapril maleate 20 MG Oral Tablet | PSN | 0c829189-fba2-48f8-a23f-d5471a0345f6 | 3 |
| 858813 | enalapril maleate 5 MG Oral Tablet | PSN | 0c829189-fba2-48f8-a23f-d5471a0345f6 | 3 |
| 858817 | enalapril maleate 10 MG Oral Tablet | SCD | 0c829189-fba2-48f8-a23f-d5471a0345f6 | 3 |
| 858804 | enalapril maleate 2.5 MG Oral Tablet | SCD | 0c829189-fba2-48f8-a23f-d5471a0345f6 | 3 |
| 858810 | enalapril maleate 20 MG Oral Tablet | SCD | 0c829189-fba2-48f8-a23f-d5471a0345f6 | 3 |
| 858813 | enalapril maleate 5 MG Oral Tablet | SCD | 0c829189-fba2-48f8-a23f-d5471a0345f6 | 3 |
| 858813 | enalapril maleate 5 MG Oral Tablet | PSN | 4f56955c-fc61-49ad-b42f-ff9d3386af6a | 2 |
| 858813 | enalapril maleate 5 MG Oral Tablet | SCD | 4f56955c-fc61-49ad-b42f-ff9d3386af6a | 2 |
| 858813 | enalapril maleate 5 MG Oral Tablet | PSN | 2cc892e2-1d91-e52a-e063-6394a90a6649 | 1 |
| 858813 | enalapril maleate 5 MG Oral Tablet | PSN | dfc439f7-83f5-4b9e-bbf2-f3d002860be3 | 1 |
| 858813 | enalapril maleate 5 MG Oral Tablet | SCD | 2cc892e2-1d91-e52a-e063-6394a90a6649 | 1 |
| 858813 | enalapril maleate 5 MG Oral Tablet | SCD | dfc439f7-83f5-4b9e-bbf2-f3d002860be3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43547-546-03 | 43547054603 | 30 TABLET in 1 BOTTLE (43547-546-03) | 30 tablet | 2022-07-31 | 0000-00-00 | No | No | Current |
| 43547-546-09 | 43547054609 | 90 TABLET in 1 BOTTLE (43547-546-09) | 90 tablet | 2022-07-31 | 0000-00-00 | No | No | Current |
| 43547-546-10 | 43547054610 | 100 TABLET in 1 BOTTLE (43547-546-10) | 100 tablet | 2022-07-31 | 0000-00-00 | No | No | Current |
| 43547-546-11 | 43547054611 | 1000 TABLET in 1 BOTTLE (43547-546-11) | 1000 tablet | 2022-07-31 | 0000-00-00 | No | No | Current |
| 43547-546-50 | 43547054650 | 500 TABLET in 1 BOTTLE (43547-546-50) | 500 tablet | 2022-07-31 | 0000-00-00 | No | No | Current |