Vecuronium Bromide

Product NDC: 63323-782
11-digit product format: 633230782
Labeler code: 63323
Product ID: 63323-782_ef0a4c9f-a65e-48dd-b625-eb76a18905f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vecuronium Bromide
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA205390
Marketing category: ANDA
Marketing start: 2016-06-30
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63323-782		D	Discontinued by firm		2026-08-17
excluded package	package	63323-782	63323-782-20	D	Discontinued by firm		2026-08-17

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205390-001	VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP		2016-05-26
A205390-002	VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP		2016-05-26

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205390-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205390-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205390-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205390-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205390-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205390-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205390-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205390-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205390-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205390-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205390-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205390-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205390-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205390-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205390-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205390-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205390-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205390-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205390-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205390-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205390-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205390-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205390-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205390-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205390-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205390-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205390-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205390-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205390-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205390-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205390-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205390-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205390-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205390-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205390-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205390-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205390-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205390-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205390-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205390-002	AP	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
ec3684c3-bbd0-48b6-aac1-2a439cf50145	Product name	2	20200114
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-782-20	Vecuronium Bromide	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		5
63323-782-23	Vecuronium Bromide	20 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	20		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-782-20	EA - Each	63323-782	fe774901-a483-4471-a686-133a02035a69	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-782	VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20221208_d3163bdf-f163-41b5-a38a-3cd6fc1a50ba.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vecuronium Bromide	VECURONIUM BROMIDE	Mullan Pharmaceutical Inc.	aa35d139-25c8-4802-b165-0db7d1c08913	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205390 application number: ANDA205390
Vecuronium Bromide	VECURONIUM BROMIDE	Sagent Pharmaceuticals	dff452e8-71e7-437e-bed0-3e1bd9441bc6	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205390 application number: ANDA205390
Vecuronium Bromide	VECURONIUM BROMIDE	Gland Pharma Limited	5ae91612-4f65-4e52-8901-c37010612eaf	2018-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205390 application number: ANDA205390

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7E4PHP5N1D	VECURONIUM BROMIDE	50700-72-6	VECURONIUM BROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
859437	vecuronium bromide 1 MG/ML Injectable Solution	PSN	d3163bdf-f163-41b5-a38a-3cd6fc1a50ba	5
859437	vecuronium bromide 1 MG/ML Injectable Solution	SCD	d3163bdf-f163-41b5-a38a-3cd6fc1a50ba	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-782-20	63323078220	10 VIAL in 1 CARTON (63323-782-20) / 20 mL in 1 VIAL (63323-782-23)	10 vial	2016-06-30	0000-00-00	No	No	Current
63323-782-23	63323078223	20 mL in 1 VIAL	20 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vecuronium Bromide for Injection	Fresenius Kabi USA, LLC \| Gland Pharma Limited	2022-12-02	Human Prescription Drug Label	5