Prescription drug · ANDA
Captopril NDC 27241-161
Captopril 25 mg/1 · Tablet · Oral · Ajanta Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27241-161-01 | 2724101610127241016101 | 100 TABLET in 1 BOTTLE (27241-161-01)Marketed from Dec 13, 2019 | |
| 27241-161-10 | 2724101611027241016110 | 1000 TABLET in 1 BOTTLE (27241-161-10)Marketed from Dec 13, 2019 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ajanta Pharma USA Inc.NDC labeler code 27241
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212809
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 27241-161_6425b4dc-ff42-4118-88dd-c369924fc080SPL ID 6425b4dc-ff42-4118-88dd-c369924fc080SPL set ID 1fbc9b28-ff10-4b17-a359-e12b4330747eRxCUI 308962, 308963, 308964, 317173UNII 9G64RSX1XDUPC 0327241160011, 0327241163012, 0327241161018, 0327241162015
- 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
N427241016101followed by a unit qualifier and the quantityPackage 27241-0161-01. 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 Hypertension: Captopril tablets, USP, are indicated for the treatment of hypertension. In using captopril tablets, USP, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets, USP 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, USP are effective alone and in combination with…
Excerpt only. Read the full label for complete information.
About NDC 27241-161
- What is NDC 27241-161?
- 27241-161 is the product NDC for Captopril, Captopril 25 mg/1 tablet, listed with the FDA by Ajanta Pharma USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Captopril.
- What is the active ingredient?
- Captopril.
- Who is the labeler?
- Ajanta Pharma USA Inc., NDC labeler code 27241. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Captopril?
- 46 other product NDCs are listed under this name. See all Captopril NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Captopril products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Captopril | Captopril 12.5 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-135 | 11788-0135-01 |
| Captopril | Captopril 25 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-136 | 11788-0136-01 |
| Captopril | Captopril 50 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-137 | 11788-0137-01 |
| Captopril | Captopril 100 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-138 | 11788-0138-01 |
| captopril | Captopril 12.5 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-935 | 58657-0935-0158657-0935-03 |
| captopril | Captopril 25 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-936 | 58657-0936-0158657-0936-03 |
| captopril | Captopril 50 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-937 | 58657-0937-0158657-0937-03 |
| captopril | Captopril 100 mg/1 | TabletOral | Method Pharmaceuticals LLC | 58657-938 | 58657-0938-0158657-0938-03 |
| Captopril | Captopril 12.5 mg/1 | TabletOral | AvKARE | 73190-026 | 73190-0026-01 |
| Captopril | Captopril 25 mg/1 | TabletOral | AvKARE | 73190-027 | 73190-0027-01 |
Other NDCs under ANDA 212809
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 | Major Pharmaceuticals | 0904-7105 |
| Captopril | Captopril 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7106 |
| Captopril | Captopril 12.5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-160 |
| Captopril | Captopril 50 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-162 |
| Captopril | Captopril 100 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-163 |
| Captopril | Captopril 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1918 |
| Captopril | Captopril 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2358 |