Home NDC 67457-438-10 VECURONIUM BROMIDE
Product NDC 67457-438
Requested package NDC 67457-438-10
11-digit product format 674570438
Labeler code 67457
Product ID 67457-438_8c9683a0-197a-4291-9dc1-fd7ce5723efe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VECURONIUM BROMIDE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA090243
Marketing category ANDA
Marketing start 2014-03-20
Substance VECURONIUM BROMIDE
Active strength 1 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 A090243-001 VECURONIUM BROMIDE VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 A090243-002 VECURONIUM BROMIDE VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11
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 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090243-001 VECURONIUM BROMIDE 10MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090243-002 VECURONIUM BROMIDE 20MG/VIAL INJECTABLE / INJECTION AP 2010-05-11 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 VECURONIUM BROMIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VECURONIUM BROMIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7E4PHP5N1D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859437 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 67457-438-00 VECURONIUM BROMIDE 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 8 67457-438-10 VECURONIUM BROMIDE 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VECURONIUM BROMIDE ACTIVE INGREDIENT 7E4PHP5N1D VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 2 VECURONIUM ACTIVE MOIETY 5438723848 VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 2 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 2 SODIUM PHOSPHATE, DIBASIC ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-438 VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 8 Current NDC, Legacy NDC, 2 package rows 20230112_96e69586-e9af-4b07-990f-12d93faa7edd.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 · 1 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 67457-438-10 67457043810 10 VIAL in 1 CARTON (67457-438-10) / 10 mL in 1 VIAL (67457-438-00) 10 vial 2014-03-20 0000-00-00 No No Current