FDA.reportPublic FDA data

Sugammadex

Product NDC
83301-0078
11-digit product format
833010078
Labeler code
83301
Product ID
83301-0078_7e2e6873-a8ed-4f4f-836f-30c7ccadd92c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SUGAMMADEX SODIUM
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Mullan Pharmaceutical Inc.
Application
ANDA215701
Marketing category
ANDA
Marketing start
2026-11-02
Substance
SUGAMMADEX SODIUM
Active strength
500 mg/5mL
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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215701-001SUGAMMADEX SODIUMSUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-10-06
A215701-002SUGAMMADEX SODIUMSUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215701-001AP
A215701-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A215701-001SUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-10-06c2088c7a36db…
2026-10-15 13:18:302026-09A215701-002SUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-10-06c2088c7a36db…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A215701-001AP1c2088c7a36db…
2026-10-15 13:18:302026-09A215701-002AP1c2088c7a36db…

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
IngredientStrength
SUGAMMADEX SODIUM500 mg/5mL

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83301-0078-28330100780210 VIAL, SINGLE-DOSE in 1 CARTON (83301-0078-2) / 5 mL in 1 VIAL, SINGLE-DOSE (83301-0078-1) 2026-11-02NoNoCurrent