Prescription drug · ANDA
captopril NDC 63629-3554
Captopril 50 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-3554-1 | 63629355401 | 90 TABLET in 1 BOTTLE (63629-3554-1)Marketed from Jun 26, 2025 |
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)
- captopril
- Generic name (nonproprietary)
- captopril
- Active ingredients
- Captopril — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074677
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-3554_3ebb6074-91f0-4937-a62f-07e5ec5266e8SPL ID 3ebb6074-91f0-4937-a62f-07e5ec5266e8SPL set ID ccbffd30-4b21-4522-bdb8-abba8d592017RxCUI 308964UNII 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
N463629355401followed by a unit qualifier and the quantityPackage 63629-3554-01. 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)
Hypertension Captopril tablets 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 antihypertensive agents, especially th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074677
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 |
|---|---|---|---|---|
| captopril | Captopril 12.5 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-735 |
| captopril | Captopril 25 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-736 |
| captopril | Captopril 50 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-737 |
| captopril | Captopril 100 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-738 |
| captopril | Captopril 12.5 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-935 |
| captopril | Captopril 25 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-936 |
| captopril | Captopril 50 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-937 |
| captopril | Captopril 100 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-938 |
| captopril | Captopril 12.5 mg/1 | TabletOral | AMICI PHARMA, INC. | 69292-522 |
| captopril | Captopril 25 mg/1 | TabletOral | AMICI PHARMA, INC. | 69292-524 |
| captopril | Captopril 50 mg/1 | TabletOral | AMICI PHARMA, INC. | 69292-526 |
| captopril | Captopril 100 mg/1 | TabletOral | AMICI PHARMA, INC. | 69292-528 |