Prescription drug · ANDA
Enalapril maleate NDC 0904-7312
Enalapril maleate 20 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7312-61 | 0090473126100904731261 | 100 BLISTER PACK in 1 CARTON (0904-7312-61) / 1 TABLET in 1 BLISTER PACKMarketed from Aug 28, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Enalapril maleate
- Generic name (nonproprietary)
- enalapril maleate
- Active ingredients
- Enalapril maleate — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075479
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 0904-7312_e94d8a16-0294-4f3e-b77a-29ed1a94d3a2SPL ID e94d8a16-0294-4f3e-b77a-29ed1a94d3a2SPL set ID 8fe8dc52-dee6-4d33-b798-e90128011f46RxCUI 858804, 858810, 858813, 858817UNII 9O25354EPJ
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400904731261followed by a unit qualifier and the quantityPackage 00904-7312-61. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Hypertension Enalapril maleate tablets USP are indicated for the treatment of hypertension. Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive. Heart Failure Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, He…
Excerpt only. Read the full label for complete information.
About NDC 0904-7312
- What is NDC 0904-7312?
- 0904-7312 is the product NDC for Enalapril maleate, Enalapril maleate 20 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Enalapril maleate.
- What is the active ingredient?
- Enalapril maleate.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Enalapril maleate?
- 97 other product NDCs are listed under this name. See all Enalapril maleate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Enalapril maleate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1254 | 67046-1254-03 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4164 | 68788-4164-0168788-4164-0368788-4164-06+1 more |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4147 | 68788-4147-0068788-4147-0368788-4147-06+1 more |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Coupler LLC | 67046-0798 | 67046-0798-03 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Amici Pharma, Inc | 69292-544 | 69292-0544-0169292-0544-1069292-0544-50 |
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Amici Pharma, Inc | 69292-540 | 69292-0540-0169292-0540-10 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Amici Pharma, Inc | 69292-542 | 69292-0542-0169292-0542-1069292-0542-50 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Amici Pharma, Inc | 69292-546 | 69292-0546-0169292-0546-10 |
| Enalapril maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7309 | 00904-7309-61 |
| Enalapril maleate | Enalapril maleate 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7310 | 00904-7310-61 |
Other NDCs under ANDA 075479
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.