FDA.reportPublic FDA data

Rocuronium Bromide

Product NDC
0264-5711
Requested package NDC
0264-5711-10
11-digit product format
002645711
Labeler code
0264
Product ID
0264-5711_123bd8e8-648e-4c54-907e-551ffd32643d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rocuronium Bromide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA219108
Marketing category
NDA
Marketing start
2026-04-24
Substance
ROCURONIUM BROMIDE
Active strength
50 mg/5mL
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219108-001ROCURONIUM BROMIDEROCURONIUM BROMIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-24

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219108-001119986052039-07-22Drug product2025-10-29

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
2026-02-19 14:30 UTC2026-02N219108-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219108-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-2431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219108-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-10-24a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N219108-001119986052039-07-22Drug product2025-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219108-001119986052039-07-22Drug product2025-10-2931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219108-001119986052039-07-22Drug product2025-10-29a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROCURONIUM BROMIDE50 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I65MW4OFHZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a54a79f7-5207-43d8-a139-7d57557caa50Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f63639fe-3389-4c7a-8765-a6005a965c6cProduct name920260316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-5711-01Rocuronium Bromide5 mL in 1 SYRINGEINJECTION53
0264-5711-10Rocuronium Bromide30 in 1 CASEINJECTION303
0264-5711-10Rocuronium Bromide10 in 1 CARTONINJECTION103

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rocuronium BromideROCURONIUM BROMIDEB. Braun Medical Inc.a54a79f7-5207-43d8-a139-7d57557caa502026-07-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 219108
application number: NDA219108
ndc (package): 0264-5711-10
ndc (product): 0264-5711
ndc11 (package): 00264571110

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2740933rocuronium bromide 50 MG in 5 ML Prefilled SyringePSNa54a79f7-5207-43d8-a139-7d57557caa503
27409335 ML rocuronium bromide 10 MG/ML Prefilled SyringeSCDa54a79f7-5207-43d8-a139-7d57557caa503
2740933rocuronium bromide 50 MG per 5 ML Prefilled SyringeSYa54a79f7-5207-43d8-a139-7d57557caa503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0264-5711-100026457111030 CARTON in 1 CASE (0264-5711-10) / 10 SYRINGE in 1 CARTON / 5 mL in 1 SYRINGE (0264-5711-01) 30 carton2026-04-24NoNoCurrent