FDA.reportPublic FDA data

Rocuronium

Product NDC
65219-697
Requested package NDC
65219-697-10
11-digit product format
652190697
Labeler code
65219
Product ID
65219-697_31c4c874-3d24-4c86-a301-ee9faf0b5c00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROCURONIUM BROMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA217472
Marketing category
NDA
Marketing start
2023-10-11
Substance
ROCURONIUM BROMIDE
Active strength
10 mg/mL
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217472-001ROCURONIUM BROMIDEROCURONIUM BROMIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-09
N217472-002ROCURONIUM BROMIDEROCURONIUM BROMIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-09

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
2026-09-14 22:38:342026-08N217472-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-0984e616aacf4f…
2026-09-14 22:38:342026-08N217472-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-0984e616aacf4f…
2026-08-18 06:07:402026-07N217472-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07N217472-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217472-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217472-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217472-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217472-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N217472-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217472-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-096a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217472-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217472-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-06-09a50c72e98297…

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
Rocuronium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROCURONIUM BROMIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2720024Internal RxNorm lookup
2720026Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a622308-7bda-4ca0-9de5-d6b3b4be3384Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f63639fe-3389-4c7a-8765-a6005a965c6cProduct name920260316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-697-01Rocuronium10 mL in 1 VIALINJECTION, SOLUTION101
65219-697-10Rocuronium10 in 1 TRAYINJECTION, SOLUTION101

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RocuroniumROCURONIUM BROMIDEFresenius Kabi USA, LLC04c9812d-5aa3-4949-ad02-c618028f1bb02026-08-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 217472
application number: NDA217472
RocuroniumROCURONIUM BROMIDEFresenius Kabi USA, LLC9a622308-7bda-4ca0-9de5-d6b3b4be33842025-07-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 217472
application number: NDA217472
ndc (package): 65219-697-10
ndc (product): 65219-697
ndc11 (package): 65219069710

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2720026rocuronium bromide 100 MG in 10 ML InjectionPSN9a622308-7bda-4ca0-9de5-d6b3b4be33841
2720024rocuronium bromide 50 MG in 5 ML InjectionPSN9a622308-7bda-4ca0-9de5-d6b3b4be33841
272002610 ML rocuronium bromide 10 MG/ML InjectionSCD9a622308-7bda-4ca0-9de5-d6b3b4be33841
27200245 ML rocuronium bromide 10 MG/ML InjectionSCD9a622308-7bda-4ca0-9de5-d6b3b4be33841
2720026rocuronium bromide 100 MG per 10 ML InjectionSY9a622308-7bda-4ca0-9de5-d6b3b4be33841
2720024rocuronium bromide 50 MG per 5 ML InjectionSY9a622308-7bda-4ca0-9de5-d6b3b4be33841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-697-106521906971010 VIAL in 1 TRAY (65219-697-10) / 10 mL in 1 VIAL (65219-697-01) 10 vial2023-10-11NoNoCurrent