Prescription drug · ANDA
glyburide NDC 65841-832
Glyburide 1.25 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-832-01 | 6584108320165841083201 | 100 TABLET in 1 BOTTLE (65841-832-01)Marketed from Jun 2, 2016 | |
| 65841-832-05 | 6584108320565841083205 | 500 TABLET in 1 BOTTLE (65841-832-05)Marketed from Jun 2, 2016 | |
| 65841-832-06 | 6584108320665841083206 | 30 TABLET in 1 BOTTLE (65841-832-06)Marketed from Jun 2, 2016 | |
| 65841-832-10 | 6584108321065841083210 | 1000 TABLET in 1 BOTTLE (65841-832-10)Marketed from Jun 2, 2016 | |
| 65841-832-16 | 6584108321665841083216 | 90 TABLET in 1 BOTTLE (65841-832-16)Marketed from Jun 2, 2016 | |
| 65841-832-77 | 6584108327765841083277 | 10 BLISTER PACK in 1 CARTON (65841-832-77) / 10 TABLET in 1 BLISTER PACK (65841-832-30)Marketed from Jun 2, 2016 |
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)
- glyburide
- Generic name (nonproprietary)
- glyburide
- Active ingredients
- Glyburide — 1.25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 65841
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206749
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 65841-832_0450d056-3523-44c3-a4cf-f4557e520ce5SPL ID 0450d056-3523-44c3-a4cf-f4557e520ce5SPL set ID 5d0e406f-285d-4716-8971-82f665345517RxCUI 197737, 310534, 310537UNII SX6K58TVWC
- Pharmacologic class
- Sulfonylurea
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
N465841083201followed by a unit qualifier and the quantityPackage 65841-0832-01. 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)
INDICATIONS AND USAGE Glyburide tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Excerpt only. Read the full label for complete information.
About NDC 65841-832
- What is NDC 65841-832?
- 65841-832 is the product NDC for glyburide, Glyburide 1.25 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- glyburide.
- What is the active ingredient?
- Glyburide.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 65841. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for glyburide?
- 51 other product NDCs are listed under this name. See all glyburide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other glyburide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glyburide | Glyburide 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4073 | 68788-4073-0168788-4073-0368788-4073-06+1 more |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1620 | 67046-1620-03 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4035 | 70518-4035-0070518-4035-01 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8508 | 68788-8508-0168788-8508-0368788-8508-06+1 more |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3504 | 70518-3504-0070518-3504-01 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6196 | 50090-6196-0050090-6196-0150090-6196-02+2 more |
| Glyburide | Glyburide 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7408 | 50090-7408-0050090-7408-02 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7859 | 50090-7859-00 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3452 | 68071-3452-0368071-3452-06 |
| Glyburide | Glyburide 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2771 | 71335-2771-0171335-2771-0271335-2771-03+3 more |
Other NDCs under ANDA 206749
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 |
|---|---|---|---|---|
| glyburide | Glyburide 2.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-833 |
| glyburide | Glyburide 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-834 |
| glyburide | Glyburide 1.25 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-656 |
| glyburide | Glyburide 2.5 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-657 |
| glyburide | Glyburide 5 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-658 |