Prescription drug · NDA
Glucagon NDC 63323-596
Glucagon hydrochloride 1 mg/mL · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-596-13 | 6332305961363323059613 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-596-13) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-11)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
- Active ingredients
- Glucagon hydrochloride — 1 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 201849
- Marketing start
- Listing expires
- Other FDA classes
- Decreased GI Motility (Physiologic effect)Decreased GI Smooth Muscle Tone (Physiologic effect)Decreased Glycolysis (Physiologic effect)Increased Gluconeogenesis (Physiologic effect)Increased Glycogenolysis (Physiologic effect)
- Identifiers
- Product ID 63323-596_eb37fc8a-a264-4ce9-a130-466e9b5f3a38SPL ID eb37fc8a-a264-4ce9-a130-466e9b5f3a38SPL set ID e4be1c0e-0fe6-45a0-9229-5cde98434b84RxCUI 310497UNII 1H87NVF4DBUPC 0363323596033
- Pharmacologic class
- Antihypoglycemic Agent; Gastrointestinal Motility Inhibitor
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463323059613followed by a unit qualifier and the quantityPackage 63323-0596-13. 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.
About NDC 63323-596
- What is NDC 63323-596?
- 63323-596 is the product NDC for Glucagon, Glucagon hydrochloride 1 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glucagon.
- What is the active ingredient?
- Glucagon hydrochloride.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glucagon?
- 12 other product NDCs are listed under this name. See all Glucagon NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glucagon products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glucagon | — | Kit | Cipla USA Inc. | 69097-027 | 69097-0027-50 |
| Glucagon | — | Kit | Sportpharm LLC | 85766-043 | 85766-0043-01 |
| Glucagon | — | Kit | Lupin Pharmaceuticals, Inc. | 70748-311 | 70748-0311-01 |
| Glucagon | — | Kit | Mylan Pharmaceuticals Inc. | 0378-8067 | 00378-8067-90 |
| Glucagon | — | Kit | Sportpharm LLC | 85766-065 | 85766-0065-01 |
| Glucagon | — | Kit | Amphastar Pharmaceuticals, Inc. | 0548-5850 | 00548-5850-00 |
| Glucagon | — | Kit | A-S Medication Solutions | 50090-6550 | 50090-6550-00 |
| Glucagon | — | Kit | Sportpharm LLC | 85766-241 | 85766-0241-01 |
| Glucagon | — | KitIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1498 | 51662-1498-01 |
| Glucagon | — | Kit | Fresenius Kabi USA, LLC | 63323-582 | 63323-0582-82 |
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 | — | KitIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1498 |
| Glucagon | — | Kit | Fresenius Kabi USA, LLC | 63323-582 |
| Glucagon | — | Kit | Fresenius Kabi USA, LLC | 63323-593 |
| Glucagon | — | Kit | Fresenius Kabi USA, LLC | 63323-594 |