Prescription drug · ANDA
Enalapril Maleate NDC 50090-6490
Enalapril maleate 5 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6490-0 | 5009064900050090649000 | 30 TABLET in 1 BOTTLE (50090-6490-0)Marketed from May 18, 2023 | |
| 50090-6490-1 | 5009064900150090649001 | 100 TABLET in 1 BOTTLE (50090-6490-1)Marketed from May 18, 2023 | |
| 50090-6490-3 | 5009064900350090649003 | 90 TABLET in 1 BOTTLE (50090-6490-3)Marketed from May 18, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075496
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 50090-6490_cdd905f1-e3c6-46b0-9ef0-38d431c4610dSPL ID cdd905f1-e3c6-46b0-9ef0-38d431c4610dSPL set ID 7b80abb4-fa75-48a4-a2e9-b0e31205234cRxCUI 858813UNII 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
N450090649000followed by a unit qualifier and the quantityPackage 50090-6490-00. 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, 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 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 improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality…
Excerpt only. Read the full label for complete information.
About NDC 50090-6490
- What is NDC 50090-6490?
- 50090-6490 is the product NDC for Enalapril Maleate, Enalapril maleate 5 mg/1 tablet, listed with the FDA by A-S Medication Solutions. It has 3 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 075496
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 | Northstar RxLLC | 16714-442 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Northstar RxLLC | 16714-443 |