Prescription drug · ANDA
Glucagon NDC 0378-8067
Kit · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-8067-90 | 0037880679000378806790 | 1 KIT in 1 KIT (0378-8067-90) * 1 mL in 1 VIAL (0378-8065-32) * 1 mL in 1 SYRINGE (0378-8066-32)Marketed from Feb 26, 2025 |
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
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204468
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-8067_e1d65360-2785-4308-8a64-5c2c9e812868SPL ID e1d65360-2785-4308-8a64-5c2c9e812868SPL set ID 15b49500-0aae-4e25-9a1d-709983233cc6RxCUI 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
N400378806790followed by a unit qualifier and the quantityPackage 00378-8067-90. 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 patie…
Excerpt only. Read the full label for complete information.
About NDC 0378-8067
- What is NDC 0378-8067?
- 0378-8067 is the product NDC for Glucagon kit, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 | 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 |
| Glucagon | — | Kit | Fresenius Kabi USA, LLC | 63323-594 | 63323-0594-03 |
Other NDCs under ANDA 204468
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 | Sportpharm LLC | 85766-065 |