Home NDC 42677-309 Rocuronium Bromide
Product NDC 42677-309
11-digit product format 426770309
Labeler code 42677
Product ID 42677-309_51ae72f8-d3d6-71e5-e063-6394a90a640d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rocuronium Bromide
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Shandong New Time Pharmaceutical Co., Ltd.
Application ANDA215684
Marketing category ANDA
Marketing start 2024-07-12
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 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 A215684-001 ROCURONIUM BROMIDE ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 A215684-002 ROCURONIUM BROMIDE ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12
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.
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 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215684-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215684-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2024-07-12 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 42677-309-01 Rocuronium Bromide 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 2 42677-309-10 Rocuronium Bromide 10 in 1 CARTON INJECTION, SOLUTION 10 2
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42677-309-01 42677030901 5 mL in 1 VIAL, MULTI-DOSE 5 ml Historical 42677-309-10 42677030910 10 VIAL, MULTI-DOSE in 1 CARTON (42677-309-10) / 5 mL in 1 VIAL, MULTI-DOSE (42677-309-01) 2024-07-12 No No Current