FDA.reportPublic FDA data

BRIDION

Product NDC
0006-5423
11-digit product format
000065423
Labeler code
0006
Product ID
0006-5423_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

Additional Listing Data#

Finished product
Yes
Brand name base
BRIDION
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUGAMMADEX SODIUM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiERJ6X2MXV7
Rxcui1726992, 1726997, 1727000, 1727001

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc2881fb-27ee-456f-af4b-321cb6a83b4aProduct name220240705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-5423-02BRIDION2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION226
0006-5423-05BRIDION5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION526
0006-5423-12BRIDION10 in 1 CARTONINJECTION, SOLUTION1026
0006-5423-15BRIDION10 in 1 CARTONINJECTION, SOLUTION1026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5423-02ML - Milliliter0006-542362e18f6b-de47-491b-82b7-9cf91ed9b05312016-02-04
0006-5423-05ML - Milliliter0006-54238409b5a5-ef27-4489-9304-1176266c26e112016-02-04
0006-5423-12ML - Milliliter0006-5423fcad661e-e8fe-40c6-a72d-c82d0308eb2212016-02-04
0006-5423-15ML - Milliliter0006-542343f4a3ce-eb9f-46d1-8954-ce8585c4f02812016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-5423BRIDION (SUGAMMADEX) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC]25Current NDC, Legacy NDC, 4 package rows20250201_5171d883-fe8f-482c-97ab-40b00975b64a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726997Bridion 200 MG in 2 ML InjectionPSN5171d883-fe8f-482c-97ab-40b00975b64a26
1727001Bridion 500 MG in 5 ML InjectionPSN5171d883-fe8f-482c-97ab-40b00975b64a26
1726992sugammadex 200 MG in 2 ML InjectionPSN5171d883-fe8f-482c-97ab-40b00975b64a26
1727000sugammadex 500 MG in 5 ML InjectionPSN5171d883-fe8f-482c-97ab-40b00975b64a26
17269972 ML sugammadex 100 MG/ML Injection [Bridion]SBD5171d883-fe8f-482c-97ab-40b00975b64a26
17270015 ML sugammadex 100 MG/ML Injection [Bridion]SBD5171d883-fe8f-482c-97ab-40b00975b64a26
17269922 ML sugammadex 100 MG/ML InjectionSCD5171d883-fe8f-482c-97ab-40b00975b64a26
17270005 ML sugammadex 100 MG/ML InjectionSCD5171d883-fe8f-482c-97ab-40b00975b64a26
17269972 ML Bridion 100 MG/ML InjectionSY5171d883-fe8f-482c-97ab-40b00975b64a26
17269972 ML Sugammadex 100 MG/ML (as sugammadex sodium 108.8 MG) Injection [Bridion]SY5171d883-fe8f-482c-97ab-40b00975b64a26
17270015 ML Bridion 100 MG/ML InjectionSY5171d883-fe8f-482c-97ab-40b00975b64a26
17270015 ML Sugammadex 100 MG/ML (as sugammadex sodium 108.8 MG) Injection [Bridion]SY5171d883-fe8f-482c-97ab-40b00975b64a26
1726997Bridion 200 MG per 2 ML InjectionSY5171d883-fe8f-482c-97ab-40b00975b64a26
1727001Bridion 500 MG per 5 ML InjectionSY5171d883-fe8f-482c-97ab-40b00975b64a26
1726992sugammadex 200 MG per 2 ML InjectionSY5171d883-fe8f-482c-97ab-40b00975b64a26
1727000sugammadex 500 MG per 5 ML InjectionSY5171d883-fe8f-482c-97ab-40b00975b64a26
1726997Bridion 200 MG in 2 ML InjectionPSN37276948-ff0f-e0ab-e063-6394a90a09733
1726992sugammadex 200 MG in 2 ML InjectionPSN37276948-ff0f-e0ab-e063-6394a90a09733
17269972 ML sugammadex 100 MG/ML Injection [Bridion]SBD37276948-ff0f-e0ab-e063-6394a90a09733
17269922 ML sugammadex 100 MG/ML InjectionSCD37276948-ff0f-e0ab-e063-6394a90a09733
17269972 ML Bridion 100 MG/ML InjectionSY37276948-ff0f-e0ab-e063-6394a90a09733
17269972 ML Sugammadex 100 MG/ML (as sugammadex sodium 108.8 MG) Injection [Bridion]SY37276948-ff0f-e0ab-e063-6394a90a09733
1726997Bridion 200 MG per 2 ML InjectionSY37276948-ff0f-e0ab-e063-6394a90a09733
1726992sugammadex 200 MG per 2 ML InjectionSY37276948-ff0f-e0ab-e063-6394a90a09733
1726997Bridion 200 MG in 2 ML InjectionPSN9e3eb206-5c35-2c93-e053-2a95a90a9df02
1726992sugammadex 200 MG in 2 ML InjectionPSN9e3eb206-5c35-2c93-e053-2a95a90a9df02
17269972 ML sugammadex 100 MG/ML Injection [Bridion]SBD9e3eb206-5c35-2c93-e053-2a95a90a9df02
17269922 ML sugammadex 100 MG/ML InjectionSCD9e3eb206-5c35-2c93-e053-2a95a90a9df02
17269972 ML Bridion 100 MG/ML InjectionSY9e3eb206-5c35-2c93-e053-2a95a90a9df02
17269972 ML Sugammadex 100 MG/ML (as sugammadex sodium 108.8 MG) Injection [Bridion]SY9e3eb206-5c35-2c93-e053-2a95a90a9df02
1726997Bridion 200 MG per 2 ML InjectionSY9e3eb206-5c35-2c93-e053-2a95a90a9df02
1726992sugammadex 200 MG per 2 ML InjectionSY9e3eb206-5c35-2c93-e053-2a95a90a9df02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-5423-02000065423022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0006-5423-05000065423055 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0006-5423-120000654231210 VIAL, SINGLE-DOSE in 1 CARTON (0006-5423-12) / 2 mL in 1 VIAL, SINGLE-DOSE (0006-5423-02) 2015-12-150000-00-00NoNoCurrent
0006-5423-150000654231510 VIAL, SINGLE-DOSE in 1 CARTON (0006-5423-15) / 5 mL in 1 VIAL, SINGLE-DOSE (0006-5423-05) 2015-12-150000-00-00NoNoCurrent