Prescription drug · ANDA
Glucagon NDC 0548-5850
Kit · Amphastar Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0548-5850-00 | 00548585000 | 1 KIT in 1 KIT (0548-5850-00) * 1 mL in 1 VIAL (0548-5905-00) * 1 mL in 1 SYRINGE (0548-5831-00)Marketed from Feb 10, 2021 |
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)
- Glucagon
- Generic name (nonproprietary)
- glucagon
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208086
- Marketing start
- Listing expires
- Identifiers
- Product ID 0548-5850_00dea931-5151-4d98-99c4-5aab553a5ad3SPL ID 00dea931-5151-4d98-99c4-5aab553a5ad3SPL set ID 8cc40354-b5ac-45b6-a211-93b44444f2a3RxCUI 310497
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400548585000followed by a unit qualifier and the quantityPackage 00548-5850-00. 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)
GLUCAGON for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. ( 1.1 ) as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. ( 1.2 ) 1.1 Severe Hypoglycemia Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. 1.2 Diagnostic Aid Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208086
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.