Home NDC 71288-700 Rocuronium Bromide
Product NDC 71288-700
11-digit product format 712880700
Labeler code 71288
Product ID 71288-700_37295b13-65a4-40fa-8d6c-53aeb45e2939
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rocuronium Bromide
Dosage form INJECTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA213453
Marketing category ANDA
Marketing start 2023-05-08
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 A213453-001 ROCURONIUM BROMIDE ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 A213453-002 ROCURONIUM BROMIDE ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08
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 2 · 44 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 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213453-001 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213453-002 ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE / INJECTION AP 2023-05-08 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 71288-700-05 Rocuronium Bromide 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 6 71288-700-06 Rocuronium Bromide 10 in 1 CARTON INJECTION 10 6 71288-700-91 Rocuronium Bromide 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 1 71288-700-92 Rocuronium Bromide 10 in 1 CARTON INJECTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-700 ROCURONIUM BROMIDE INJECTION [MEITHEAL PHARMACEUTICALS INC.] 6 Current NDC, 2 package rows 20230511_b9abaf64-760d-43e0-8669-a9ca70feab11.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 · 2 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 71288-700-05 71288070005 5 mL in 1 VIAL, MULTI-DOSE 5 ml Historical 71288-700-06 71288070006 10 VIAL, MULTI-DOSE in 1 CARTON (71288-700-06) / 5 mL in 1 VIAL, MULTI-DOSE (71288-700-05) 2023-05-08 No No Current 71288-700-91 71288070091 5 mL in 1 VIAL, MULTI-DOSE 5 ml Historical 71288-700-92 71288070092 10 VIAL, MULTI-DOSE in 1 CARTON (71288-700-92) / 5 mL in 1 VIAL, MULTI-DOSE (71288-700-91) 2023-05-08 No No Current