Prescription drug · ANDA
Captopril NDC 43547-365
Captopril 50 mg/1 · Tablet · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-365-10 | 43547036510 | 100 TABLET in 1 BOTTLE (43547-365-10)Marketed from Jul 1, 2016 | |
| 43547-365-11 | 43547036511 | 1000 TABLET in 1 BOTTLE (43547-365-11)Marketed from Jul 1, 2016 |
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)
- Captopril
- Generic name (nonproprietary)
- captopril
- Active ingredients
- Captopril — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare US, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074477
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 43547-365_cdf43721-a18a-42c8-8354-ae99e7be261aSPL ID cdf43721-a18a-42c8-8354-ae99e7be261aSPL set ID 2d3779b0-83d9-4b6f-a043-f7768cd7fce6RxCUI 308962, 308963, 308964, 317173UNII 9G64RSX1XD
- 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
N443547036510followed by a unit qualifier and the quantityPackage 43547-0365-10. 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: Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihyper…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074477
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.