Prescription drug · ANDA
Enalaprilat NDC 43598-078
Enalaprilat 1.25 mg/mL · Injection · Intravenous · Dr. Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-078-58 | 43598007858 | 10 VIAL in 1 CARTON (43598-078-58) / 1 mL in 1 VIAL (43598-078-11)Marketed from Jun 6, 2023 |
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)
- Enalaprilat
- Generic name (nonproprietary)
- enalaprilat
- Active ingredients
- Enalaprilat — 1.25 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Dr. Reddys Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075578
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 43598-078_d20e2c0a-b04d-5e4a-a28b-442e0a77f3b6SPL ID d20e2c0a-b04d-5e4a-a28b-442e0a77f3b6SPL set ID 5d398da1-020c-ccb1-a775-ce8e0b29d621RxCUI 1729200, 1729205UNII GV0O7ES0R3UPC 0343598078113, 0343598169118, 0343598078588, 0343598169583
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N443598007858followed by a unit qualifier and the quantityPackage 43598-0078-58. 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 Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension. In using enalaprilat injection, 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 di…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075578
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 |
|---|---|---|---|---|
| Enalaprilat | Enalaprilat 2.5 mg/2mL | InjectionIntravenous | Dr. Reddys Laboratories Inc | 43598-169 |