Home NDC 39822-4200 rocuronium bromide
Product NDC 39822-4200
11-digit product format 398224200
Labeler code 39822
Product ID 39822-4200_eedcfb07-4e23-3152-e053-2995a90a6e6a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rocuronium bromide
Dosage form SOLUTION
Route INTRAVENOUS
Labeler XGen Pharmaceuticals DJB, Inc.
Application ANDA091115
Marketing category ANDA
Marketing start 2012-12-01
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 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 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 39822-4200-1 rocuronium bromide 5 mL in 1 VIAL SOLUTION 5 20 39822-4200-2 rocuronium bromide 10 in 1 CARTON SOLUTION 10 20 39822-4200-5 rocuronium bromide 10 mL in 1 VIAL SOLUTION 10 20 39822-4200-6 rocuronium bromide 10 in 1 CARTON SOLUTION 10 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ROCURONIUM BROMIDE ACTIVE INGREDIENT I65MW4OFHZ ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] 6 ROCURONIUM ACTIVE MOIETY WRE554RFEZ ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] 6 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] 6 NITROGEN INACTIVE INGREDIENT N762921K75 ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] 6 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] 6 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39822-4200 ROCURONIUM BROMIDE SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] 20 Current NDC, Legacy NDC, 4 package rows 20221217_b73f192c-2912-4ec3-9b4f-05a58d9b35ba.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 ndc (product): 39822-4200 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
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 39822-4200-1 39822420001 5 mL in 1 VIAL 5 ml Historical 39822-4200-2 39822420002 10 VIAL in 1 CARTON (39822-4200-2) / 5 mL in 1 VIAL (39822-4200-1) 10 vial 2012-12-01 0000-00-00 No No Current 39822-4200-5 39822420005 10 mL in 1 VIAL 10 ml Historical 39822-4200-6 39822420006 10 VIAL in 1 CARTON (39822-4200-6) / 10 mL in 1 VIAL (39822-4200-5) 10 vial 2012-12-01 0000-00-00 No No Current