Prescription drug · ANDA
Repaglinide NDC 62135-947
Repaglinide 1 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-947-90 | 6213509479062135094790 | 90 TABLET in 1 BOTTLE (62135-947-90)Marketed from Apr 24, 2025 |
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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078555
- Marketing start
- Listing expires
- Other FDA classes
- Potassium Channel Antagonists (Mechanism)
- Identifiers
- Product ID 62135-947_342983dc-ded9-2234-e063-6294a90ac97fSPL ID 342983dc-ded9-2234-e063-6294a90ac97fSPL set ID cb995e92-295e-4638-a064-978211f5afe1RxCUI 200256, 200257, 200258UNII 668Z8C33LUUPC 0362135948900, 0362135947903, 0362135946906
- 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
N462135094790followed by a unit qualifier and the quantityPackage 62135-0947-90. 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 is 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.
About NDC 62135-947
- What is NDC 62135-947?
- 62135-947 is the product NDC for Repaglinide, Repaglinide 1 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Repaglinide.
- What is the active ingredient?
- Repaglinide.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Repaglinide?
- 17 other product NDCs are listed under this name. See all Repaglinide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Repaglinide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Repaglinide | Repaglinide .5 mg/1 | TabletOral | NorthStar RxLLC | 72603-810 | 72603-0810-01 |
| Repaglinide | Repaglinide 1 mg/1 | TabletOral | NorthStar RxLLC | 72603-811 | 72603-0811-01 |
| Repaglinide | Repaglinide 2 mg/1 | TabletOral | NorthStar RxLLC | 72603-812 | 72603-0812-01 |
| Repaglinide | Repaglinide .5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-248 | 33342-0248-1133342-0248-44 |
| Repaglinide | Repaglinide 1 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-249 | 33342-0249-1133342-0249-44 |
| Repaglinide | Repaglinide 2 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-250 | 33342-0250-1133342-0250-44 |
| Repaglinide | Repaglinide .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2554 | 71335-2554-0171335-2554-02 |
| Repaglinide | Repaglinide 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2598 | 71335-2598-01 |
| Repaglinide | Repaglinide 1 mg/1 | TabletOral | American Health Packaging | 60687-560 | 60687-0560-21 |
| Repaglinide | Repaglinide .5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-157 | 57237-0157-0157237-0157-05 |
Other NDCs under ANDA 078555
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 .5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-946 |
| Repaglinide | Repaglinide 2 mg/1 | TabletOral | Chartwell RX, LLC | 62135-948 |