sugammadex

Product NDC: 55579-893
11-digit product format: 555790893
Labeler code: 55579
Product ID: 55579-893_5c275b08-0e93-d6a7-e063-6294a90adf63
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SUGAMMADEX
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Solupharm Pharmazeutische Erzeugnisse GmbH
Application: ANDA215260
Marketing category: ANDA
Marketing start: 2026-07-28
Substance: SUGAMMADEX SODIUM
Active strength: 100 mg/mL
Pharmacologic classes: gamma-Cyclodextrins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215260-001	SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2026-07-28
A215260-002	SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2026-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A215260-001	AP
A215260-002	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215260-001	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2026-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215260-002	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2026-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215260-001	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2026-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215260-002	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2026-07-28	`caaa826d4ba7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215260-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215260-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215260-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215260-002	AP	1	`caaa826d4ba7…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SUGAMMADEX SODIUM	100 mg/mL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sugammadex	SUGAMMADEX	Medical Purchasing Solutions, LLC	5b14e457-5ea1-3fe2-e063-6294a90aff6f	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215260 application number: ANDA215260
sugammadex	SUGAMMADEX SODIUM	Solupharm Pharmazeutische Erzeugnisse GmbH	f92c4e53-13d1-46f2-acf8-6730c3cfac69	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215260 application number: ANDA215260
sugammadex	SUGAMMADEX	Somerset Therapeutics, LLC	70c00636-d4ba-4939-802c-9d5a92435c93	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215260 application number: ANDA215260

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ERJ6X2MXV7	SUGAMMADEX SODIUM	343306-79-6	SUGAMMADEX SODIUM
361LPM2T56	SUGAMMADEX	343306-71-8	SUGAMMADEX

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
55579-893-10	55579089310	10 VIAL, SINGLE-DOSE in 1 CARTON (55579-893-10) / 5 mL in 1 VIAL, SINGLE-DOSE (55579-893-01)	2026-07-28	No	No	Current