Prescription drug · ANDA
Repaglinide NDC 57237-159
Repaglinide 2 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-159-01 | 57237015901 | 100 TABLET in 1 BOTTLE (57237-159-01)Marketed from Jan 22, 2014 | |
| 57237-159-05 | 57237015905 | 500 TABLET in 1 BOTTLE (57237-159-05)Marketed from Jan 22, 2014 |
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)
- Repaglinide
- Generic name (nonproprietary)
- repaglinide
- Active ingredients
- Repaglinide — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203820
- Marketing start
- Listing expires
- Other FDA classes
- Potassium Channel Antagonists (Mechanism)
- Identifiers
- Product ID 57237-159_641cf1c4-6d24-4ad7-b85a-b2ddbb9263c4SPL ID 641cf1c4-6d24-4ad7-b85a-b2ddbb9263c4SPL set ID d7673e22-0dbb-4395-ad60-943d249203a1RxCUI 200256, 200257, 200258UNII 668Z8C33LUUPC 0357237157015, 0357237158012, 0357237159019
- Pharmacologic class
- Glinide
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
N457237015901followed by a unit qualifier and the quantityPackage 57237-0159-01. 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 .
Indications (excerpt from the label)
Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of Use: Repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Repaglinide tablets are a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Limitation of Use : Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203820
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 |
|---|---|---|---|---|
| Repaglinide | Repaglinide 1 mg/1 | TabletOral | American Health Packaging | 60687-560 |
| Repaglinide | Repaglinide 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-672 |
| Repaglinide | Repaglinide .5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-670 |
| Repaglinide | Repaglinide 1 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-671 |
| Repaglinide | Repaglinide .5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4866 |
| Repaglinide | Repaglinide 1 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2558 |
| Repaglinide | Repaglinide .5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-157 |
| Repaglinide | Repaglinide 1 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-158 |