Prescription drug · ANDA
Glipizide NDC 71335-2353
Glipizide 10 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2353-1 | 7133523530171335235301 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2353-1)Marketed from Feb 21, 2024 | |
| 71335-2353-2 | 7133523530271335235302 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2353-2)Marketed from Feb 21, 2024 | |
| 71335-2353-3 | 7133523530371335235303 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2353-3)Marketed from Feb 21, 2024 | |
| 71335-2353-4 | 7133523530471335235304 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2353-4)Marketed from Feb 21, 2024 | |
| 71335-2353-5 | 7133523530571335235305 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2353-5)Marketed from Feb 21, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Glipizide
- Generic name (nonproprietary)
- glipizide
- Active ingredients
- Glipizide — 10 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206928
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 71335-2353_bb8758a7-c9c3-4a5f-b96f-3cb8957535c9SPL ID bb8758a7-c9c3-4a5f-b96f-3cb8957535c9SPL set ID 2aa01a7e-a703-426f-9cd3-70b88d0a8e7fRxCUI 315107UNII X7WDT95N5C
- 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
N471335235301followed by a unit qualifier and the quantityPackage 71335-2353-01. 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)
Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide extended-release tablets is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis 1.1 Limitations of Use Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Excerpt only. Read the full label for complete information.
About NDC 71335-2353
- What is NDC 71335-2353?
- 71335-2353 is the product NDC for Glipizide, Glipizide 10 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glipizide.
- What is the active ingredient?
- Glipizide.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glipizide?
- 135 other product NDCs are listed under this name. See all Glipizide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glipizide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glipizide | Glipizide 5 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-117 | 11788-0117-0111788-0117-0511788-0117-10 |
| Glipizide | Glipizide 10 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-118 | 11788-0118-00 |
| Glipizide | Glipizide 2.5 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-120 | 11788-0120-0111788-0120-0511788-0120-10 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-579 | 72789-0579-3072789-0579-6072789-0579-86+3 more |
| Glipizide | Glipizide 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-580 | 72789-0580-3072789-0580-6072789-0580-86+3 more |
| Glipizide | Glipizide 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4178 | 68788-4178-0168788-4178-0368788-4178-06+2 more |
| Glipizide | Glipizide 10 mg/1 | TabletOral | Coupler LLC | 67046-0367 | 67046-0367-03 |
| Glipizide | Glipizide 5 mg/1 | TabletOral | Coupler LLC | 67046-0236 | 67046-0236-03 |
| Glipizide | Glipizide 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4061 | 68788-4061-0168788-4061-0368788-4061-06+2 more |
| Glipizide | Glipizide 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4017 | 68788-4017-0168788-4017-0368788-4017-06+2 more |
Other NDCs under ANDA 206928
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 |
|---|---|---|---|---|
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6746 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6765 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 59651-781 |
| Glipizide | Glipizide 2.5 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-768 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-881 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-793 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-794 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3898 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4128 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-9742 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2614 |
| Glipizide | Glipizide 5 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 82868-025 |
| Glipizide | Glipizide 10 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 82868-035 |