Home NDC 25021-619 Sugammadex
Product NDC 25021-619
11-digit product format 250210619
Labeler code 25021
Product ID 25021-619_56db464b-e9db-4a9b-bb38-b5ddfa0fc6b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sugammadex Sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA215575
Marketing category ANDA
Marketing start 2026-07-01
Substance SUGAMMADEX SODIUM
Active strength 100 mg/mL
Pharmacologic classes gamma-Cyclodextrins [CS]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog .
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Sugammadex
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUGAMMADEX SODIUM 100 mg/mL
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 Units Marketing start Sample Status 25021-619-02 25021061902 10 VIAL in 1 CARTON (25021-619-02) / 2 mL in 1 VIAL 10 vial 2026-07-01 0 Current 25021-619-05 25021061905 10 VIAL in 1 CARTON (25021-619-05) / 5 mL in 1 VIAL 10 vial 2026-07-01 0 Current