Prescription drug · ANDA
Repaglinide NDC 65862-671
Repaglinide 1 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-671-01 | 6586206710165862067101 | 100 TABLET in 1 BOTTLE (65862-671-01)Marketed from Jan 22, 2014 | |
| 65862-671-05 | 6586206710565862067105 | 500 TABLET in 1 BOTTLE (65862-671-05)Marketed from Jan 22, 2014 | |
| 65862-671-99 | 6586206719965862067199 | 1000 TABLET in 1 BOTTLE (65862-671-99)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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- 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 65862-671_54d938ac-ebf2-49d0-8056-f65d8aadfb98SPL ID 54d938ac-ebf2-49d0-8056-f65d8aadfb98SPL set ID 68064989-47ea-4ed5-a20e-43c4ef6ec271RxCUI 200256, 200257, 200258UNII 668Z8C33LUUPC 0365862670014, 0365862672018, 0365862671011
- 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
N465862067101followed by a unit qualifier and the quantityPackage 65862-0671-01. 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.
About NDC 65862-671
- What is NDC 65862-671?
- 65862-671 is the product NDC for Repaglinide, Repaglinide 1 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, 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?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 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 .5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-157 |
| Repaglinide | Repaglinide 1 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-158 |
| Repaglinide | Repaglinide 2 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-159 |
| Repaglinide | Repaglinide 1 mg/1 | TabletOral | American Health Packaging | 60687-560 |
| Repaglinide | Repaglinide .5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4866 |
| Repaglinide | Repaglinide 1 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2558 |