rocuronium bromide

Product NDC: 0409-5160
11-digit product format: 004095160
Labeler code: 0409
Product ID: 0409-5160_f01f9986-43f9-40e8-9506-11bfe78f9242
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rocuronium bromide
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA205656
Marketing category: ANDA
Marketing start: 2023-08-28
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: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205656-001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04
A205656-002	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205656-001	AP
A205656-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205656-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205656-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205656-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205656-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205656-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205656-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205656-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205656-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205656-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205656-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205656-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205656-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205656-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205656-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205656-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205656-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205656-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205656-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205656-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205656-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205656-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205656-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205656-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205656-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205656-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205656-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205656-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205656-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205656-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205656-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205656-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205656-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205656-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205656-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205656-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205656-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205656-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205656-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205656-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205656-002	AP	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: rocuronium bromide
Listing expiration: 2026-12-31

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
f01f9986-43f9-40e8-9506-11bfe78f9242	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f63639fe-3389-4c7a-8765-a6005a965c6c	Product name	9	20260316
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-5160-01	rocuronium bromide	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10		1
0409-5160-10	rocuronium bromide	10 in 1 CARTON	INJECTION, SOLUTION	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-5160-01	ML - Milliliter	0409-5160	0a14bd3d-51bc-4c5b-91cc-a471b9fac723	1	2023-10-16
0409-5160-10	ML - Milliliter	0409-5160	d72f8fc3-8fd6-4196-9578-712579fe7cf7	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-5160	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	1	Current NDC, 2 package rows	20230910_f01f9986-43f9-40e8-9506-11bfe78f9242.zip

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rocuronium Bromide	ROCURONIUM BROMIDE	ProPharma Distribution	579c4dfd-4877-33bb-e063-6394a90ae3d9	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656
Rocuronium Bromide	ROCURONIUM BROMIDE	Gland Pharma Limited	a223a740-dbe8-4d06-8b8b-d9104b694e62	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	15897860-d6a9-07e5-e063-6394a90aec75	2024-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	074abb29-72d9-b09f-e063-6294a90af0a9	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656
rocuronium bromide	ROCURONIUM BROMIDE	Hospira, Inc.	f01f9986-43f9-40e8-9506-11bfe78f9242	2023-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656 ndc (product): 0409-5160
Rocuronium Bromide	ROCURONIUM BROMIDE	Sagent Pharmaceuticals	01825411-be08-4402-b101-cb546291c972	2023-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656
rocuronium bromide	ROCURONIUM BROMIDE	Hospira, Inc.	c96726ef-f1fa-4ebb-ba33-3479c3902a8e	2023-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1234995	rocuronium bromide 10 MG/ML Injectable Solution	PSN	f01f9986-43f9-40e8-9506-11bfe78f9242	1
1234995	rocuronium bromide 10 MG/ML Injectable Solution	SCD	f01f9986-43f9-40e8-9506-11bfe78f9242	1
1234995	rocuronium bromide 100 MG per 10 ML Concentrate for Injectable Solution	SY	f01f9986-43f9-40e8-9506-11bfe78f9242	1
1234995	rocuronium bromide 50 MG per 5 ML Concentrate for Injectable Solution	SY	f01f9986-43f9-40e8-9506-11bfe78f9242	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0409-5160-01	00409516001	10 mL in 1 VIAL, MULTI-DOSE	10 ml				Historical
0409-5160-10	00409516010	10 VIAL, MULTI-DOSE in 1 CARTON (0409-5160-10) / 10 mL in 1 VIAL, MULTI-DOSE (0409-5160-01)		2023-08-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
rocuronium bromide	Hospira, Inc. \| Gland Chemicals Private Limited \| GLAND PHARMA LIMITED	2023-08-29	Human Prescription Drug Label	1