Sugammadex

Product NDC: 25021-619
Requested package NDC: 25021-619-05
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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sugammadex	SUGAMMADEX SODIUM	Sagent Pharmaceuticals	5b25f16e-726a-4464-88da-b188c2f4e038	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215575 application number: ANDA215575 ndc (package): 25021-619-05 ndc (product): 25021-619 ndc11 (package): 25021061905

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5b25f16e-726a-4464-88da-b188c2f4e038	Available on FDA.report

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ERJ6X2MXV7	SUGAMMADEX SODIUM	343306-79-6	SUGAMMADEX SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
25021-619-05	25021061905	10 VIAL in 1 CARTON (25021-619-05) / 5 mL in 1 VIAL	10 vial	2026-07-01	0	Current