ROCURONIUM BROMIDE

Product NDC: 51662-1710
11-digit product format: 516621710
Labeler code: 51662
Product ID: 51662-1710_58b92bce-5ff9-6741-e063-6294a90a25e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ROCURONIUM BROMIDE
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: HF Acquisition Co. LLC, DBA HealthFirst
Application: ANDA204679
Marketing category: ANDA
Marketing start: 2017-04-30
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
A204679-001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2017-02-28
A204679-002	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2017-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204679-001	AP
A204679-002	AP

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204679-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204679-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204679-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204679-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204679-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204679-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204679-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204679-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204679-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204679-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204679-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204679-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204679-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204679-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204679-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204679-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204679-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204679-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204679-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204679-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204679-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204679-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204679-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204679-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204679-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204679-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204679-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204679-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204679-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204679-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204679-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204679-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204679-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204679-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204679-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204679-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204679-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204679-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204679-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204679-002	AP	1	`74a2ff9319b5…`

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 BROMIDE
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
1234995	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
58b92bce-5ff8-6741-e063-6294a90a25e9	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rocuronium Bromide	ROCURONIUM BROMIDE	HF Acquisition Co. LLC, DBA HealthFirst	58ce3f40-cbb9-db9e-e063-6394a90ae611	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204679 application number: ANDA204679
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co. LLC, DBA HealthFirst	58b92bce-5ff8-6741-e063-6294a90a25e9	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204679 application number: ANDA204679 ndc (product): 51662-1710
Rocuronium Bromide	ROCURONIUM BROMIDE	Civica, Inc.	8ea475c7-d35e-47f4-8955-0df5ccd35b79	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204679 application number: ANDA204679
Rocuronium Bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	15ea777f-2ba9-7f60-e063-6294a90a539b	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204679 application number: ANDA204679
Rocuronium Bromide	ROCURONIUM BROMIDE	Hikma Pharmaceuticals USA Inc.	d3a172a5-01ab-47d8-92ac-a8539b1d4dc4	2023-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204679 application number: ANDA204679

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
51662-1710-1	51662171001	10 mL in 1 VIAL (51662-1710-1)	10 ml	2017-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
51662-1710 Rocuronium Bromide	HF Acquisition Co. LLC, DBA HealthFirst	2026-08-10	HUMAN PRESCRIPTION DRUG LABEL	1