Home NDC 0409-9558 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 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 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.
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 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…2022-03-09 01:35 UTC 2022-03 A078519-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-11-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078519-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-11-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078519-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-11-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078519-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-11-26 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
DailyMed RxNorm Mappings# 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