Prescription drug · ANDA
Glimepiride 3 mg (Glimepiride) NDC 72336-641
Glimepiride 3 mg/1 · Tablet · Oral · Lifsa Drugs LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72336-641-01 | 7233606410172336064101 | 100 TABLET in 1 BOTTLE (72336-641-01)Marketed from Aug 20, 2024 |
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)
- Glimepiride 3 mg
- Generic name (nonproprietary)
- glimepiride
- Active ingredients
- Glimepiride — 3 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lifsa Drugs LLCNDC labeler code 72336
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091220
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 72336-641_8f56950f-d08d-44d4-9c7c-9830e9bfadb8SPL ID 8f56950f-d08d-44d4-9c7c-9830e9bfadb8SPL set ID 51157849-7990-4a8b-ae50-eda1baf93cfaRxCUI 153842UNII 6KY687524KUPC 0372336641012
- 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
N472336064101followed by a unit qualifier and the quantityPackage 72336-0641-01. 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)
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1) ] . Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ). Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 72336-641
- What is NDC 72336-641?
- 72336-641 is the product NDC for Glimepiride 3 mg (glimepiride), Glimepiride 3 mg/1 tablet, listed with the FDA by Lifsa Drugs LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glimepiride 3 mg (Glimepiride).
- What is the active ingredient?
- Glimepiride.
- Who is the labeler?
- Lifsa Drugs LLC, NDC labeler code 72336. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glimepiride 3 mg?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 091220
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 |
|---|---|---|---|---|
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8332 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8333 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8334 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Micro Labs Limited | 42571-100 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Micro Labs Limited | 42571-101 |
| Glimepiride | Glimepiride 3 mg/1 | TabletOral | Micro Labs Limited | 42571-102 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Micro Labs Limited | 42571-103 |
| Glimepiride | Glimepiride 6 mg/1 | TabletOral | Micro Labs Limited | 42571-104 |
| Glimepiride | Glimepiride 8 mg/1 | TabletOral | Micro Labs Limited | 42571-105 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | BluePoint Laboratories | 68001-584 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | BluePoint Laboratories | 68001-585 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | BluePoint Laboratories | 68001-586 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1885 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1886 |