Prescription drug · ANDA
Glimepiride NDC 43063-121
Glimepiride 1 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-121-30 | 43063012130 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-121-30)Marketed from Dec 23, 2009 | |
| 43063-121-90 | 43063012190 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-121-90)Marketed from Dec 23, 2009 |
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
- Generic name (nonproprietary)
- glimepiride
- Active ingredients
- Glimepiride — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077091
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 43063-121_4137398e-13df-7c18-e063-6394a90ac45dSPL ID 4137398e-13df-7c18-e063-6394a90ac45dSPL set ID 657f1b51-2f82-44f6-a23d-97f4b34b3c45RxCUI 199245UNII 6KY687524KUPC 0343063121900
- 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
N443063012130followed by a unit qualifier and the quantityPackage 43063-0121-30. 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 tablets are 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.
Other NDCs under ANDA 077091
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 2 mg/1 | TabletOral | American Health Packaging | 68084-326 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3043 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-489 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Proficient Rx LP | 82804-140 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-8175 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2228 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-565 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-122 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-1006 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-321 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | American Health Packaging | 68084-788 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-320 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-322 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-6852 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2385 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-6415 |
| Glimepiride | Glimepiride 4 mg/1 | TabletOral | American Health Packaging | 68084-327 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-6910 |
| Glimepiride | Glimepiride 1 mg/1 | TabletOral | AvPAK | 50268-358 |
| Glimepiride | Glimepiride 2 mg/1 | TabletOral | AvPAK | 50268-359 |
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