Vecuronium Bromide

Product NDC
83301-0056
11-digit product format
833010056
Labeler code
83301
Product ID
83301-0056_a5076db5-099f-43a9-9116-4743f258da76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vecuronium Bromide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Mullan Pharmaceutical Inc.
Application
ANDA205390
Marketing category
ANDA
Marketing start
2025-12-05
Substance
VECURONIUM BROMIDE
Active strength
10 mg/10mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205390-001VECURONIUM BROMIDEVECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-26
A205390-002VECURONIUM BROMIDEVECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A205390-001AP
A205390-002AP

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-26caaa826d4ba7…
2026-08-18 06:07:402026-07A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205390-001VECURONIUM BROMIDE10MG/VIALINJECTABLE / INJECTIONAP2016-05-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205390-002VECURONIUM BROMIDE20MG/VIALINJECTABLE / INJECTIONAP2016-05-26bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205390-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A205390-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205390-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205390-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205390-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205390-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205390-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205390-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205390-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205390-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205390-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205390-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205390-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205390-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205390-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205390-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205390-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205390-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205390-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205390-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205390-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205390-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205390-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205390-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205390-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205390-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205390-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205390-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205390-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205390-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205390-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205390-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205390-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205390-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205390-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205390-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205390-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205390-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205390-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205390-002AP1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Vecuronium Bromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VECURONIUM BROMIDE10 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7E4PHP5N1DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
859437Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa35d139-25c8-4802-b165-0db7d1c08913Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
ec3684c3-bbd0-48b6-aac1-2a439cf50145Product name220200114
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0056-1Vecuronium Bromide10 mL in 1 VIALINJECTION102
83301-0056-2Vecuronium Bromide10 in 1 CARTONINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0056-1EA - Each83301-0056504c5a1e-cbf2-4178-a39f-3a2d68f64dcc12026-02-05
83301-0056-2EA - Each83301-00562c467e3d-1017-4884-81e1-538b8470fe0a12026-02-05

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vecuronium BromideVECURONIUM BROMIDEMullan Pharmaceutical Inc.aa35d139-25c8-4802-b165-0db7d1c089132025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205390
application number: ANDA205390
ndc (product): 83301-0056
Vecuronium BromideVECURONIUM BROMIDESagent Pharmaceuticalsdff452e8-71e7-437e-bed0-3e1bd9441bc62024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205390
application number: ANDA205390
Vecuronium BromideVECURONIUM BROMIDEGland Pharma Limited5ae91612-4f65-4e52-8901-c37010612eaf2018-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205390
application number: ANDA205390

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859437vecuronium bromide 1 MG/ML Injectable SolutionPSNaa35d139-25c8-4802-b165-0db7d1c089132
859437vecuronium bromide 1 MG/ML Injectable SolutionSCDaa35d139-25c8-4802-b165-0db7d1c089132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83301-0056-18330100560110 mL in 1 VIAL10 mlHistorical
83301-0056-28330100560210 VIAL in 1 CARTON (83301-0056-2) / 10 mL in 1 VIAL (83301-0056-1) 10 vial2025-12-05NoNoCurrent