Home NDC 67457-969 Sugammadex
Product NDC 67457-969
11-digit product format 674570969
Labeler code 67457
Product ID 67457-969_eb84def8-933b-4eba-b81f-30d40b1e3d8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sugammadex
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA213915
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 A213915-001 SUGAMMADEX SODIUM SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2026-07-28 A213915-002 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.
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 RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A213915-001 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 A213915-002 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 A213915-001 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 A213915-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2026-07-28 caaa826d4ba7…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213915-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-15 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213915-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213915-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-15 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213915-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-06-15 a67488948f0b…
Observed Orange Book normalized TE history# 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
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726992 Internal RxNorm lookup 1727000 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 67457-969-02 67457096902 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-969-02) / 2 mL in 1 VIAL, SINGLE-DOSE (67457-969-00) 2026-07-28 No No Current