sugammadex
- Product NDC
- 16729-727
- Requested package NDC
- 16729-727-03
- 11-digit product format
- 167290727
- Labeler code
- 16729
- Product ID
- 16729-727_584eff57-3033-e86e-e063-6394a90aa30f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sugammadex
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA214306
- Marketing category
- ANDA
- Marketing start
- 2026-08-04
- Substance
- SUGAMMADEX SODIUM
- Active strength
- 500 mg/5mL
- Pharmacologic classes
- gamma-Cyclodextrins [CS]
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- sugammadex
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SUGAMMADEX SODIUM | 500 mg/5mL |
Harmonized UNII identifiers#
UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| ERJ6X2MXV7 | Internal UNII lookup |
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Status |
|---|
| 16729-727-03 | 16729072703 | 10 VIAL, SINGLE-DOSE in 1 CARTON (16729-727-03) / 5 mL in 1 VIAL, SINGLE-DOSE | 2026-08-04 | 0 | Current |