Sugammadex
- Product NDC
- 42677-312
- Requested package NDC
- 42677-312-10
- 11-digit product format
- 426770312
- Labeler code
- 42677
- Product ID
- 42677-312_311349c8-b612-9697-e063-6294a90ad245
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sugammadex
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Shandong New Time Pharmaceutical Co., Ltd.
- Application
- ANDA215701
- Marketing category
- ANDA
- Marketing start
- 2025-05-01
- Substance
- SUGAMMADEX SODIUM
- Active strength
- 100 mg/mL
- Pharmacologic classes
- gamma-Cyclodextrins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sugammadex
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SUGAMMADEX SODIUM | 100 mg/mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42677-312-10 | 42677031210 | 10 VIAL, SINGLE-DOSE in 1 CARTON (42677-312-10) / 5 mL in 1 VIAL, SINGLE-DOSE (42677-312-01) | 2025-05-01 | No | No | Current |