Home NDC 0006-5425 BRIDION
Product NDC 0006-5425
11-digit product format 000065425
Labeler code 0006
Product ID 0006-5425_26634a32-bcb0-478d-a176-1bf6c6d6f1b3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sugammadex
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Merck Sharp & Dohme LLC
Application NDA022225
Marketing category NDA
Marketing start 2015-12-15
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 1 .
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 N022225-001 BRIDION SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 N022225-002 BRIDION SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 N022225-001 RE44733*PED 2026-07-27 Pediatric extension N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 N022225-002 RE44733*PED 2026-07-27 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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.
Product history page 1 of 3 · 82 observed 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 2026-02-19 14:30 UTC 2026-02 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2015-12-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2015-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2015-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2015-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2015-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2015-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2015-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022225-001 BRIDION EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022225-002 BRIDION EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2015-12-15 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 4 · 128 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022225-001 RE44733*PED 2026-07-27 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022225-002 RE44733*PED 2026-07-27 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022225-001 RE44733*PED 2026-07-27 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022225-002 RE44733*PED 2026-07-27 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022225-001 RE44733*PED 2026-07-27 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022225-002 RE44733*PED 2026-07-27 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022225-001 RE44733*PED 2026-07-27 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022225-002 RE44733*PED 2026-07-27 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022225-001 RE44733*PED 2026-07-27 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022225-002 RE44733*PED 2026-07-27 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022225-001 RE44733*PED 2026-07-27 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022225-002 RE44733*PED 2026-07-27 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022225-001 RE44733*PED 2026-07-27 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022225-002 RE44733*PED 2026-07-27 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022225-001 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022225-002 RE44733 2026-01-27 U-1794 Drug substance, Drug product 2016-01-12 1e350fbaab3a…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 162 observed states.
Additional Listing Data#
Finished product Yes
Brand name base BRIDION
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726992 Internal RxNorm lookup 1726997 Internal RxNorm lookup 1727000 Internal RxNorm lookup 1727001 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0006-5425-05 BRIDION 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 26 0006-5425-15 BRIDION 10 in 1 CARTON INJECTION, SOLUTION 10 26
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-5425 BRIDION (SUGAMMADEX) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC] 25 Current NDC, Legacy NDC, 2 package rows 20250201_5171d883-fe8f-482c-97ab-40b00975b64a.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0006-5425-05 00006542505 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 0006-5425-15 00006542515 10 VIAL, SINGLE-DOSE in 1 CARTON (0006-5425-15) / 5 mL in 1 VIAL, SINGLE-DOSE (0006-5425-05) 2017-06-05 0000-00-00 No No Current