Home NDC 42677-312-10 Sugammadex
Product NDC 42677-312
Requested package NDC 42677-312-10
11-digit product format 426770312
Labeler code 42677
Product ID 42677-312_311349c8-b612-9697-e063-6294a90ad245
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sugammadex
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Shandong New Time Pharmaceutical Co., Ltd.
Application ANDA215701
Marketing category ANDA
Marketing start 2025-05-01
Substance SUGAMMADEX SODIUM
Active strength 100 mg/mL
Pharmacologic classes gamma-Cyclodextrins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215701-001 SUGAMMADEX SODIUM SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2026-10-06 A215701-002 SUGAMMADEX SODIUM SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2026-10-06
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 2026-10-15 13:18:30 2026-09 A215701-001 SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2026-10-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A215701-002 SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP 2026-10-06 c2088c7a36db…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A215701-001 AP 1 c2088c7a36db…2026-10-15 13:18:30 2026-09 A215701-002 AP 1 c2088c7a36db…
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 2026-12-31 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42677-312-10 42677031210 10 VIAL, SINGLE-DOSE in 1 CARTON (42677-312-10) / 5 mL in 1 VIAL, SINGLE-DOSE (42677-312-01) 2025-05-01 No No Current