Prescription drug · ANDA
Sugammadex NDC 0781-3469
Sugammadex sodium 500 mg/5mL · Injection, Solution · Intravenous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3469-95 | 0078134699500781346995 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3469-95) / 5 mL in 1 VIAL, SINGLE-DOSE (0781-3469-72)Marketed from Jul 28, 2026 |
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)
- Sugammadex
- Generic name (nonproprietary)
- sugammadex
- Active ingredients
- Sugammadex sodium — 500 mg/5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214311
- Marketing start
- Listing expires
- Other FDA classes
- gamma-Cyclodextrins (Chemical structure)
- Identifiers
- Product ID 0781-3469_6cf43d88-d410-439e-a2e5-e31086f14fc2SPL ID 6cf43d88-d410-439e-a2e5-e31086f14fc2SPL set ID 6cf43d88-d410-439e-a2e5-e31086f14fc2RxCUI 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
N400781346995followed by a unit qualifier and the quantityPackage 00781-3469-95. 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.
About NDC 0781-3469
- What is NDC 0781-3469?
- 0781-3469 is the product NDC for Sugammadex, Sugammadex sodium 500 mg/5mL injection, solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sugammadex.
- What is the active ingredient?
- Sugammadex sodium.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sugammadex?
- 35 other product NDCs are listed under this name. See all Sugammadex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sugammadex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| sugammadex | Sugammadex sodium 200 mg/2mL | Injection, SolutionIntravenous | Accord Healthcare Inc. | 16729-726 | 16729-0726-03 |
| sugammadex | Sugammadex sodium 500 mg/5mL | Injection, SolutionIntravenous | Accord Healthcare Inc. | 16729-727 | 16729-0727-03 |
| sugammadex | Sugammadex sodium 200 mg/2mL | Injection, SolutionIntravenous | Fosun Pharma USA Inc. | 72266-268 | 72266-0268-10 |
| sugammadex | Sugammadex sodium 500 mg/5mL | Injection, SolutionIntravenous | Fosun Pharma USA Inc. | 72266-269 | 72266-0269-10 |
| Sugammadex | Sugammadex sodium 200 mg/2mL | InjectionIntravenous | B. Braun Medical Inc. | 0264-8200 | 00264-8200-10 |
| Sugammadex | Sugammadex sodium 100 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6270 | 00641-6270-10 |
| Sugammadex | Sugammadex sodium 200 mg/2mL | Injection, SolutionIntravenous | Sandoz Inc | 0781-3468 | 00781-3468-95 |
| Sugammadex | Sugammadex sodium 200 mg/2mL | Injection, SolutionIntravenous | Dr. Reddy's Laboratories Inc. | 43598-924 | 43598-0924-26 |
| Sugammadex | Sugammadex sodium 500 mg/5mL | Injection, SolutionIntravenous | Dr. Reddy's Laboratories Inc. | 43598-925 | 43598-0925-37 |
| sugammadexsugammadex sodium | Sugammadex sodium 100 mg/mL | Injection, SolutionIntravenous | Solupharm Pharmazeutische Erzeugnisse GmbH | 55579-892 | 55579-0892-10 |
Other NDCs under ANDA 214311
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 200 mg/2mL | Injection, SolutionIntravenous | Sandoz Inc | 0781-3468 |