Prescription drug · ANDA
Enalapril Maleate and Hydrochlorothiazide NDC 51672-4046
Enalapril maleate 10 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-4046-1 | 51672404601 | 100 TABLET in 1 BOTTLE (51672-4046-1)Marketed from Sep 18, 2001 | |
| 51672-4046-3 | 51672404603 | 1000 TABLET in 1 BOTTLE (51672-4046-3)Marketed from Sep 18, 2001 |
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 and Hydrochlorothiazide
- Generic name (nonproprietary)
- enalapril maleate and hydrochlorothiazide
- Active ingredients
- Enalapril maleate — 10 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075788
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 51672-4046_5699d24d-8bf5-0759-e063-6394a90ad9a3SPL ID 5699d24d-8bf5-0759-e063-6394a90ad9a3SPL set ID 7cb92cf2-46f2-4379-937c-168d230e43a4RxCUI 858824, 858828UNII 0J48LPH2TH, 9O25354EPJ
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor; Thiazide Diuretic
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
N451672404601followed by a unit qualifier and the quantityPackage 51672-4046-01. 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 Enalapril maleate and hydrochlorothiazide is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION ). In using enalapril maleate and hydrochlorothiazide, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril does not have a similar risk (see WARNINGS ). In considering use of enalapril maleate and hydrochlorothiazide, it should be noted that black patients receiving…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075788
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 and Hydrochlorothiazide | Enalapril maleate 5 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4045 |
- openFDA data updated
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