Rocuronium

Product NDC: 76045-221
11-digit product format: 760450221
Labeler code: 76045
Product ID: 76045-221_fbd1fcf9-ffaa-46f6-81ca-18d3fbc1dcee
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217472-001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-06-09
N217472-002	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-06-09

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217472-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217472-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217472-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217472-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217472-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217472-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217472-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217472-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217472-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217472-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217472-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217472-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-06-09	`a50c72e98297…`

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
Ingredient	Strength
ROCURONIUM BROMIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I65MW4OFHZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2740933	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
04c9812d-5aa3-4949-ad02-c618028f1bb0	Available on FDA.report

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	04c9812d-5aa3-4949-ad02-c618028f1bb0	2026-08-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217472 application number: NDA217472 ndc (product): 76045-221
Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	9a622308-7bda-4ca0-9de5-d6b3b4be3384	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217472 application number: NDA217472

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I65MW4OFHZ	ROCURONIUM BROMIDE	119302-91-9	ROCURONIUM BROMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76045-221-50	76045022150	10 SYRINGE in 1 CARTON (76045-221-50) / 5 mL in 1 SYRINGE (76045-221-05)	10 syringe	2026-07-06	No	No	Current