Prescription drug · ANDA
Enalapril Maleate NDC 43547-547
Enalapril maleate 10 mg/1 · Tablet · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-547-03 | 4354705470343547054703 | 30 TABLET in 1 BOTTLE (43547-547-03)Marketed from Jul 31, 2022 | |
| 43547-547-09 | 4354705470943547054709 | 90 TABLET in 1 BOTTLE (43547-547-09)Marketed from Jul 31, 2022 | |
| 43547-547-10 | 4354705471043547054710 | 100 TABLET in 1 BOTTLE (43547-547-10)Marketed from Jul 31, 2022 | |
| 43547-547-11 | 4354705471143547054711 | 1000 TABLET in 1 BOTTLE (43547-547-11)Marketed from Jul 31, 2022 | |
| 43547-547-50 | 4354705475043547054750 | 500 TABLET in 1 BOTTLE (43547-547-50)Marketed from Jul 31, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare US, LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213273
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 43547-547_f83529df-fce5-42ce-bcd4-c7f61f2a0936SPL ID f83529df-fce5-42ce-bcd4-c7f61f2a0936SPL set ID 0c829189-fba2-48f8-a23f-d5471a0345f6RxCUI 858804, 858810, 858813, 858817UNII 9O25354EPJUPC 0343547548100, 0343547546106, 0343547547103, 0343547545109
- 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
N443547054703followed by a unit qualifier and the quantityPackage 43547-0547-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Hypertension Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive. Heart Failure Enalapril maleate tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets improve symptoms, increase survival, and decrease the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Tr…
Excerpt only. Read the full label for complete information.
About NDC 43547-547
- What is NDC 43547-547?
- 43547-547 is the product NDC for Enalapril Maleate, Enalapril maleate 10 mg/1 tablet, listed with the FDA by Solco Healthcare US, LLC. It has 5 package NDCs, 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?
- Solco Healthcare US, LLC, NDC labeler code 43547. 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 213273
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-545 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-546 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-548 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7302 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-575 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Coupler LLC | 67046-0798 |
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1254 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Coupler LLC | 67046-1504 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1793 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3408 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3537 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3820 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8320 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Preferred Pharmaceuicals Inc. | 68788-8385 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8437 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3572 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4011 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4197 |
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4210 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2382 |
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