Prescription drug · ANDA
Sugammadex NDC 67457-970
Sugammadex sodium 100 mg/mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-970-05 | 67457097005 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-970-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-970-00)Marketed from Jul 28, 2026 |
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)
- Sugammadex
- Generic name (nonproprietary)
- sugammadex
- Active ingredients
- Sugammadex sodium — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213915
- Marketing start
- Listing expires
- Other FDA classes
- gamma-Cyclodextrins (Chemical structure)
- Identifiers
- Product ID 67457-970_eb84def8-933b-4eba-b81f-30d40b1e3d8dSPL ID eb84def8-933b-4eba-b81f-30d40b1e3d8dSPL set ID eb84def8-933b-4eba-b81f-30d40b1e3d8dRxCUI 1726992, 1727000UNII ERJ6X2MXV7
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
N467457097005followed by a unit qualifier and the quantityPackage 67457-0970-05. 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)
Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s BRIDION ® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information. Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213915
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 |
|---|---|---|---|---|
| Sugammadex | Sugammadex sodium 100 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-969 |