FDA.reportPublic FDA data

sugammadex

Product NDC
68083-441
11-digit product format
680830441
Labeler code
68083
Product ID
68083-441_6aaa0d1d-5de2-4a9c-8ac7-301c09579c3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sugammadex
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA214364
Marketing category
ANDA
Marketing start
2026-07-28
Substance
SUGAMMADEX SODIUM
Active strength
200 mg/2mL
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214364-001SUGAMMADEX SODIUMSUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28
A214364-002SUGAMMADEX SODIUMSUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214364-001AP
A214364-002AP

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
2026-09-14 22:38:342026-08A214364-001SUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-2884e616aacf4f…
2026-09-14 22:38:342026-08A214364-002SUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-2884e616aacf4f…
2026-08-18 06:07:402026-07A214364-001SUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A214364-002SUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214364-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A214364-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A214364-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A214364-002AP1caaa826d4ba7…

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 SODIUM200 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ERJ6X2MXV7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1726992Internal RxNorm lookup
1727000Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c61ee55a-e61b-4d3c-9ebc-cbf57290e36cAvailable on FDA.report

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sugammadexSUGAMMADEXGland Pharma Limitedc61ee55a-e61b-4d3c-9ebc-cbf57290e36c2026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214364
application number: ANDA214364
ndc (product): 68083-441
sugammadexSUGAMMADEXGLENMARK PHARMACEUTICALS INC., USAe7897fc1-4553-460c-a29b-0bc91cd9ca102026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214364
application number: ANDA214364
sugammadexSUGAMMADEXFosun Pharma USA Inc.4f1c7cf8-3db7-3f92-e063-6394a90aece92026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214364
application number: ANDA214364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68083-441-106808304411010 VIAL, SINGLE-DOSE in 1 CARTON (68083-441-10) / 2 mL in 1 VIAL, SINGLE-DOSE2026-07-28NoNoCurrent