FDA.reportPublic FDA data

SUGAMMADEX SODIUM

Product NDC
42023-830
Requested package NDC
42023-830-10
11-digit product format
420230830
Labeler code
42023
Product ID
42023-830_57d27f48-e8f1-531b-e063-6294a90ac2cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SUGAMMADEX SODIUM
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Par Health USA, LLC
Application
ANDA218814
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
A218814-001SUGAMMADEX SODIUMSUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28
A218814-002SUGAMMADEX 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
A218814-001AP
A218814-002AP

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 22:38:342026-08A218814-001SUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-2884e616aacf4f…
2026-09-14 22:38:342026-08A218814-002SUGAMMADEX SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-2884e616aacf4f…
2026-08-18 06:07:402026-07A218814-001SUGAMMADEX SODIUMEQ 200MG BASE/2ML (EQ 100MG BASE/ML)SOLUTION / INTRAVENOUSAP2026-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A218814-002SUGAMMADEX 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 22:38:342026-08A218814-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A218814-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A218814-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A218814-002AP1caaa826d4ba7…

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 SODIUM
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
2748156Internal RxNorm lookup
2748158Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
579a2a1f-4d0c-4851-e063-6294a90a2be6Available 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUGAMMADEX SODIUMSUGAMMADEX SODIUMPar Health USA, LLC579a2a1f-4d0c-4851-e063-6294a90a2be62026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218814
application number: ANDA218814
ndc (package): 42023-830-10
ndc (product): 42023-830
ndc11 (package): 42023083010
SUGAMMADEX SODIUMSUGAMMADEX SODIUMSTERISCIENCE SPECIALTIES PRIVATE LIMITED0379799d-b678-4eb1-8f15-7dd183ee2a6e2026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218814
application number: ANDA218814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42023-830-104202308301010 SYRINGE in 1 CARTON (42023-830-10) / 2 mL in 1 SYRINGE10 syringe2026-07-28YesNoCurrent