Prescription drug · NDA
Glucagon NDC 63323-593
Kit · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-593-03 | 63323059303 | 1 KIT in 1 CARTON (63323-593-03) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-03) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-185-03)Marketed from May 8, 2015 |
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)
- Glucagon
- Generic name (nonproprietary)
- glucagon
- Dosage form
- Kit
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 201849
- Marketing start
- Listing expires
- Identifiers
- Product ID 63323-593_eb37fc8a-a264-4ce9-a130-466e9b5f3a38SPL ID eb37fc8a-a264-4ce9-a130-466e9b5f3a38SPL set ID e4be1c0e-0fe6-45a0-9229-5cde98434b84RxCUI 310497UNII 1H87NVF4DBUPC 0363323596033
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
N463323059303followed by a unit qualifier and the quantityPackage 63323-0593-03. 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. 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 NDA 201849
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 |
|---|---|---|---|---|
| Glucagon | — | Kit | Fresenius Kabi USA, LLC | 63323-582 |
| Glucagon | Glucagon hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-596 |
| Glucagon | — | Kit | Fresenius Kabi USA, LLC | 63323-594 |
| Glucagon | Glucagon hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-596 |
| Glucagon | — | KitIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1498 |