ROCURONIUM BROMIDE

Product NDC: 0409-9558
11-digit product format: 004099558
Labeler code: 0409
Product ID: 0409-9558_3e8928e4-d2cc-4fbe-89a0-f04e0f5e08f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ROCURONIUM BROMIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA078519
Marketing category: ANDA
Marketing start: 2008-12-15
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
A078519-001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2008-11-26
A078519-002	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2008-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078519-001	AP
A078519-002	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	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078519-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078519-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`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	A078519-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078519-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078519-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078519-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078519-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078519-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078519-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078519-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078519-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078519-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078519-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078519-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078519-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078519-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078519-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078519-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078519-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078519-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078519-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078519-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078519-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078519-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078519-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078519-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078519-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078519-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078519-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078519-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078519-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078519-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078519-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078519-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078519-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078519-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078519-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078519-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078519-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078519-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078519-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078519-002	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
cccd40ca-5f08-4acb-8548-3cad558388bb	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	SPL version
0409-9558-05	Rocuronium Bromide	10 in 1 BOX	INJECTION, SOLUTION	10	29
0409-9558-10	Rocuronium Bromide	10 in 1 BOX	INJECTION, SOLUTION	10	29
0409-9558-11	Rocuronium Bromide	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	29
0409-9558-31	Rocuronium Bromide	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	29
0409-9558-49	ROCURONIUM BROMIDE	10 in 1 BOX	INJECTION, SOLUTION	10	14
0409-9558-50	ROCURONIUM BROMIDE	10 in 1 BOX	INJECTION, SOLUTION	10	14
0409-9558-69	ROCURONIUM BROMIDE	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	14
0409-9558-70	ROCURONIUM BROMIDE	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-9558-05	ML - Milliliter	0409-9558	76ef3541-29b6-4894-b97a-6de05914c0f5	1	2012-07-24
0409-9558-10	ML - Milliliter	0409-9558	3a085b04-cdb3-4642-8f63-1a0303b04fd2	1	2012-07-24
0409-9558-11	ML - Milliliter	0409-9558	67418593-3473-4d6a-8e00-203b5591f8e1	1	2020-01-03
0409-9558-31	ML - Milliliter	0409-9558	f0a0badc-151a-4891-9f33-c7540517b783	1	2020-02-13
0409-9558-49	ML - Milliliter	0409-9558	48aace5d-1ceb-48c5-9487-0aef323e324e	1	2012-07-24
0409-9558-50	ML - Milliliter	0409-9558	d83e760d-a00b-4365-8396-7c46bc261bb5	1	2012-07-24
0409-9558-69	ML - Milliliter	0409-9558	b6d4c76a-bde5-41b3-a6ed-d81c4c006b22	1	2020-02-13
0409-9558-70	ML - Milliliter	0409-9558	89be01fb-24c3-4f9c-8eb4-ecee46c06c31	1	2020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ROCURONIUM BROMIDE	ACTIVE INGREDIENT	I65MW4OFHZ	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	15
ROCURONIUM	ACTIVE MOIETY	WRE554RFEZ	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	15
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	15
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	15
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	15
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	15
ROCURONIUM BROMIDE	ACTIVE INGREDIENT	I65MW4OFHZ	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	2
ROCURONIUM	ACTIVE MOIETY	WRE554RFEZ	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	2
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	2
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-9558	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	27	Current NDC, Legacy NDC, 4 package rows	20241122_309aeb1b-8022-4df7-8194-ae6529e3395c.zip
0409-9558	ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12	Current NDC, Legacy NDC, 4 package rows	20241122_cccd40ca-5f08-4acb-8548-3cad558388bb.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	Hospira, Inc.	cccd40ca-5f08-4acb-8548-3cad558388bb	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078519 application number: ANDA078519 ndc (product): 0409-9558
Rocuronium Bromide	ROCURONIUM BROMIDE	Hospira, Inc.	309aeb1b-8022-4df7-8194-ae6529e3395c	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078519 application number: ANDA078519 ndc (product): 0409-9558
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	81628de9-e6bf-8f69-e053-2991aa0a6023	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078519 application number: ANDA078519
Rocuronium Bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	9f68e273-9b0e-99e3-e053-2995a90a02d1	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078519 application number: ANDA078519
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	818f7cc6-2c3f-1788-e053-2991aa0a4c6a	2021-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078519 application number: ANDA078519

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	309aeb1b-8022-4df7-8194-ae6529e3395c	29
1234995	rocuronium bromide 10 MG/ML Injectable Solution	SCD	309aeb1b-8022-4df7-8194-ae6529e3395c	29
1234995	rocuronium bromide 100 MG per 10 ML Concentrate for Injectable Solution	SY	309aeb1b-8022-4df7-8194-ae6529e3395c	29
1234995	rocuronium bromide 50 MG per 5 ML Concentrate for Injectable Solution	SY	309aeb1b-8022-4df7-8194-ae6529e3395c	29
1234995	rocuronium bromide 10 MG/ML Injectable Solution	PSN	cccd40ca-5f08-4acb-8548-3cad558388bb	14
1234995	rocuronium bromide 10 MG/ML Injectable Solution	SCD	cccd40ca-5f08-4acb-8548-3cad558388bb	14
1234995	rocuronium bromide 100 MG per 10 ML Concentrate for Injectable Solution	SY	cccd40ca-5f08-4acb-8548-3cad558388bb	14
1234995	rocuronium bromide 50 MG per 5 ML Concentrate for Injectable Solution	SY	cccd40ca-5f08-4acb-8548-3cad558388bb	14
1234995	rocuronium bromide 10 MG/ML Injectable Solution	PSN	81628de9-e6bf-8f69-e053-2991aa0a6023	5
1234995	rocuronium bromide 10 MG/ML Injectable Solution	SCD	81628de9-e6bf-8f69-e053-2991aa0a6023	5
1234995	rocuronium bromide 100 MG per 10 ML Concentrate for Injectable Solution	SY	81628de9-e6bf-8f69-e053-2991aa0a6023	5
1234995	rocuronium bromide 50 MG per 5 ML Concentrate for Injectable Solution	SY	81628de9-e6bf-8f69-e053-2991aa0a6023	5
1234995	rocuronium bromide 10 MG/ML Injectable Solution	PSN	818f7cc6-2c3f-1788-e053-2991aa0a4c6a	3
1234995	rocuronium bromide 10 MG/ML Injectable Solution	SCD	818f7cc6-2c3f-1788-e053-2991aa0a4c6a	3
1234995	rocuronium bromide 100 MG per 10 ML Concentrate for Injectable Solution	SY	818f7cc6-2c3f-1788-e053-2991aa0a4c6a	3
1234995	rocuronium bromide 50 MG per 5 ML Concentrate for Injectable Solution	SY	818f7cc6-2c3f-1788-e053-2991aa0a4c6a	3
1234995	rocuronium bromide 10 MG/ML Injectable Solution	PSN	9f68e273-9b0e-99e3-e053-2995a90a02d1	2
1234995	rocuronium bromide 10 MG/ML Injectable Solution	SCD	9f68e273-9b0e-99e3-e053-2995a90a02d1	2
1234995	rocuronium bromide 100 MG per 10 ML Concentrate for Injectable Solution	SY	9f68e273-9b0e-99e3-e053-2995a90a02d1	2
1234995	rocuronium bromide 50 MG per 5 ML Concentrate for Injectable Solution	SY	9f68e273-9b0e-99e3-e053-2995a90a02d1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-9558-05	00409955805	10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-05) / 5 mL in 1 VIAL, MULTI-DOSE (0409-9558-11)		2008-12-01	0000-00-00	No	No	Current
0409-9558-10	00409955810	10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-10) / 10 mL in 1 VIAL, MULTI-DOSE (0409-9558-31)		2008-12-01	0000-00-00	No	No	Current
0409-9558-11	00409955811	5 mL in 1 VIAL, MULTI-DOSE	5 ml					Historical
0409-9558-31	00409955831	10 mL in 1 VIAL, MULTI-DOSE	10 ml					Historical
0409-9558-49	00409955849	10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-49) / 5 mL in 1 VIAL, MULTI-DOSE (0409-9558-69)		2008-12-15	0000-00-00	No	No	Current
0409-9558-50	00409955850	10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-50) / 10 mL in 1 VIAL, MULTI-DOSE (0409-9558-70)		2008-12-15	0000-00-00	No	No	Current
0409-9558-69	00409955869	5 mL in 1 VIAL, MULTI-DOSE	5 ml					Historical
0409-9558-70	00409955870	10 mL in 1 VIAL, MULTI-DOSE	10 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROCURONIUM BROMIDE	Hospira, Inc. \| Hospira Worldwide, LLC	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	14
Rocuronium Bromide	Hospira, Inc. \| Hospira Worldwide, LLC	2026-03-09	HUMAN PRESCRIPTION DRUG LABEL	29
ROCURONIUM BROMIDE INJ. 50mg/5mL (10mg/mL) 5mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-28	HUMAN PRESCRIPTION DRUG LABEL	5
Rocuronium Bromide	Medical Purchasing Solutions, LLC	2023-05-03	HUMAN PRESCRIPTION DRUG LABEL	2
ROCURONIUM BROMIDE INJ. 100mg/10mL (10mg/mL) 10mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	3