Prescription drug · ANDA
Indapamide NDC 0228-2597
Indapamide 1.25 mg/1 · Tablet, Film coated · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0228-2597-11 | 0022825971100228259711 | 100 TABLET, FILM COATED in 1 BOTTLE (0228-2597-11)Marketed from Jan 2, 2007 | |
| 0228-2597-96 | 0022825979600228259796 | 1000 TABLET, FILM COATED in 1 BOTTLE (0228-2597-96)Marketed from Jan 2, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Indapamide
- Generic name (nonproprietary)
- indapamide
- Active ingredients
- Indapamide — 1.25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0228
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074722
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 0228-2597_c007dc5c-fc00-450f-8b79-3ab3038de5fdSPL ID c007dc5c-fc00-450f-8b79-3ab3038de5fdSPL set ID a8a4ec2c-9d4b-482b-ad29-88185c96db74RxCUI 197815, 197816UNII F089I0511L
- Pharmacologic class
- Thiazide-like 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
N400228259711followed by a unit qualifier and the quantityPackage 00228-2597-11. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS ). Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical c…
Excerpt only. Read the full label for complete information.
About NDC 0228-2597
- What is NDC 0228-2597?
- 0228-2597 is the product NDC for Indapamide, Indapamide 1.25 mg/1 tablet, film coated, listed with the FDA by Actavis Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Indapamide.
- What is the active ingredient?
- Indapamide.
- Who is the labeler?
- Actavis Pharma, Inc., NDC labeler code 0228. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Indapamide?
- 15 other product NDCs are listed under this name. See all Indapamide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Indapamide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Indapamide | Indapamide 2.5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-591 | 72189-0591-60 |
| Indapamide | Indapamide 1.25 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-875 | 16571-0875-01 |
| Indapamide | Indapamide 2.5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-876 | 16571-0876-01 |
| Indapamide | Indapamide 2.5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7247 | 68788-7247-0168788-7247-0368788-7247-06+1 more |
| Indapamide | Indapamide 2.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7826 | 50090-7826-01 |
| Indapamide | Indapamide 1.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7828 | 50090-7828-00 |
| Indapamide | Indapamide 1.25 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 62559-510 | 62559-0510-01 |
| Indapamide | Indapamide 2.5 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 62559-511 | 62559-0511-01 |
| Indapamide | Indapamide 1.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1953 | 63629-1953-01 |
| Indapamide | Indapamide 2.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1954 | 63629-1954-01 |
Other NDCs under ANDA 074722
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 |
|---|---|---|---|---|
| Indapamide | Indapamide 2.5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7247 |