Home NDC 43066-007 Rocuronium Bromide
Product NDC 43066-007
11-digit product format 430660007
Labeler code 43066
Product ID 43066-007_9e0317de-2d78-4fd8-8926-4c7b476f3ed4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rocuronium Bromide
Dosage form INJECTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA091115
Marketing category ANDA
Marketing start 2019-07-15
Substance ROCURONIUM BROMIDE
Active strength 50 mg/5mL
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 A091115-001 ROCURONIUM BROMIDE ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 A091115-002 ROCURONIUM BROMIDE ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27
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 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091115-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091115-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2012-08-27 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROCURONIUM BROMIDE 50 mg/5mL
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 43066-007-10 Rocuronium Bromide 10 in 1 CARTON INJECTION 10 7 43066-007-10 Rocuronium Bromide 5 mL in 1 VIAL INJECTION 5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43066-007 ROCURONIUM BROMIDE INJECTION [BAXTER HEALTHCARE CORPORATION] 6 Current NDC, Legacy NDC, 2 package rows 20241017_31e15c3f-aefa-4379-b684-7707744fe40d.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 Medical Purchasing Solutions, LLC 0943a290-49e8-600f-e063-6294a90a3370 2023-11-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091115 application number: ANDA091115 rocuronium bromide ROCURONIUM BROMIDE Medical Purchasing Solutions, LLC 6ba5364d-52e8-a4c0-e053-2991aa0a9e2e 2023-05-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091115 application number: ANDA091115 Rocuronium Bromide ROCURONIUM BROMIDE Medical Purchasing Solutions, LLC c8e9bdfb-1121-6f5b-e053-2a95a90a4627 2023-05-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091115 application number: ANDA091115 rocuronium bromide ROCURONIUM BROMIDE XGen Pharmaceuticals DJB, Inc. b73f192c-2912-4ec3-9b4f-05a58d9b35ba 2022-12-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091115 application number: ANDA091115 Rocuronium Bromide ROCURONIUM BROMIDE Baxter Healthcare Corporation 31e15c3f-aefa-4379-b684-7707744fe40d 2019-09-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091115 application number: ANDA091115 ndc (product): 43066-007
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 43066-007-10 43066000710 10 VIAL in 1 CARTON (43066-007-10) / 5 mL in 1 VIAL 10 vial 2019-07-15 0000-00-00 No No Current