Home NDC 63323-426 Rocuronium
Product NDC 63323-426
11-digit product format 633230426
Labeler code 63323
Product ID 63323-426_3f4d5e11-2c14-4406-8954-04dba2fc65ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ROCURONIUM BROMIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA078651
Marketing category ANDA
Marketing start 2009-12-13
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 A078651-001 ROCURONIUM BROMIDE ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 A078651-002 ROCURONIUM BROMIDE ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29
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 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078651-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078651-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2008-12-29 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
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 63323-426-01 Rocuronium 10 mL in 1 VIAL INJECTION, SOLUTION 10 10 63323-426-02 Rocuronium 5 mL in 1 VIAL INJECTION, SOLUTION 5 10 63323-426-05 Rocuronium 10 in 1 TRAY INJECTION, SOLUTION 10 10 63323-426-10 Rocuronium 10 in 1 TRAY INJECTION, SOLUTION 10 10 63323-426-12 Rocuronium 5 mL in 1 VIAL INJECTION, SOLUTION 5 2 63323-426-15 Rocuronium 10 in 1 TRAY INJECTION, SOLUTION 10 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ROCURONIUM BROMIDE ACTIVE INGREDIENT I65MW4OFHZ ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 ROCURONIUM ACTIVE MOIETY WRE554RFEZ ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-426 ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 10 Current NDC, Legacy NDC, 4 package rows 20230426_f1933332-1ae0-4dc1-be4c-694849e6c9f9.zip 63323-426 ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20230201_fb9524b2-c353-4747-8954-7ca2529eabb2.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 · 4 matching rows.
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 63323-426-01 63323042601 10 mL in 1 VIAL 10 ml Historical 63323-426-02 63323042602 5 mL in 1 VIAL 5 ml Historical 63323-426-05 63323042605 10 VIAL in 1 TRAY (63323-426-05) / 5 mL in 1 VIAL (63323-426-02) 10 vial 2009-12-13 0000-00-00 No No Current 63323-426-10 63323042610 10 VIAL in 1 TRAY (63323-426-10) / 10 mL in 1 VIAL (63323-426-01) 10 vial 2009-12-13 0000-00-00 No No Current 63323-426-12 63323042612 5 mL in 1 VIAL 5 ml Historical 63323-426-15 63323042615 10 VIAL in 1 TRAY (63323-426-15) / 5 mL in 1 VIAL (63323-426-12) 10 vial 2009-12-13 No No Current