Prescription drug · NDA
Glucotrol XL (Glipizide) NDC 0049-0174
Glipizide 5 mg/1 · Tablet, Extended release · Oral · Roerig
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0049-0174-02 | 0004901740200049017402 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-02)Marketed from May 9, 2013 | |
| 0049-0174-03 | 0004901740300049017403 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-03)Marketed from May 9, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Glucotrol XLSuffix: XL
- Generic name (nonproprietary)
- glipizide
- Active ingredients
- Glipizide — 5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- RoerigNDC labeler code 0049
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020329
- Marketing start
- Marketing end
- Other FDA classes
- Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 0049-0174_c98a3ab5-faeb-4d79-8bcd-05f37c2b50bfSPL ID c98a3ab5-faeb-4d79-8bcd-05f37c2b50bfSPL set ID eed99b60-d043-4249-9b2a-f05e46fb588dRxCUI 310489, 314006, 315107, 865568, 865571, 865573UNII X7WDT95N5CUPC 0300490174022, 0300490170017
- 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
N400049017402followed by a unit qualifier and the quantityPackage 00049-0174-02. 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)
GLUCOTROL XL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. GLUCOTROL XL 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 GLUCOTROL XL is not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Excerpt only. Read the full label for complete information.
About NDC 0049-0174
- What is NDC 0049-0174?
- 0049-0174 is the product NDC for Glucotrol XL (glipizide), Glipizide 5 mg/1 tablet, extended release, listed with the FDA by Roerig. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glucotrol XL (Glipizide).
- What is the active ingredient?
- Glipizide.
- Who is the labeler?
- Roerig, NDC labeler code 0049. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glucotrol XL?
- 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.