Prescription drug · NDA
Glucagon NDC 63323-594
Kit · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-594-03 | 6332305940363323059403 | 1 KIT in 1 CARTON (63323-594-03) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-06) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-185-03)Marketed from Dec 1, 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, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 201849
- Marketing start
- Listing expires
- Identifiers
- Product ID 63323-594_9e17207f-b348-4be8-8416-2f0aa1392390SPL ID 9e17207f-b348-4be8-8416-2f0aa1392390SPL set ID 8c8acad6-44cc-43aa-966b-027e053be8f5RxCUI 310497UNII 1H87NVF4DBUPC 0363323185039, 0363323596088, 0363323596064
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
N463323059403followed by a unit qualifier and the quantityPackage 63323-0594-03. 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 indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. Limitations of Use : Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility. Glucagon for Injection is a gastrointestinal motility inhibitor indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal (GI) tract ( 1 ) Limitations of Use: Glucagon for Injection is not indicated for the emer…
Excerpt only. Read the full label for complete information.
About NDC 63323-594
- What is NDC 63323-594?
- 63323-594 is the product NDC for Glucagon kit, 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.
- 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 | Glucagon hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-596 |