Bloxiverz

Product NDC
51754-1220
Requested package NDC
51754-1220-3
11-digit product format
517541220
Labeler code
51754
Product ID
51754-1220_01a3c204-e31a-4d0b-bb9f-5877b44c2dba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neostigmine Methylsulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Exela Pharma Sciences, LLC
Application
NDA204078
Marketing category
NDA
Marketing start
2013-07-24
Marketing end
0000-00-00
Substance
NEOSTIGMINE METHYLSULFATE
Active strength
1 mg/mL
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51754-122051754-1220-3IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204078-001BLOXIVERZNEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSRLD2013-05-31
N204078-002BLOXIVERZNEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2013-05-31
N204078-003BLOXIVERZNEOSTIGMINE METHYLSULFATE5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2023-10-27

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 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSRLD2013-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2013-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-10-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2023-10-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2023-10-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2023-10-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2023-10-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2023-10-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204078-002BLOXIVERZ10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204078-003BLOXIVERZ5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2023-10-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204078-001BLOXIVERZ5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2013-05-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204078-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204078-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N204078-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204078-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204078-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204078-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204078-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204078-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204078-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204078-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204078-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204078-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204078-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204078-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204078-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204078-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204078-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N204078-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204078-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204078-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204078-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204078-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204078-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204078-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204078-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N204078-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204078-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204078-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204078-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N204078-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204078-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N204078-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204078-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204078-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204078-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N204078-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204078-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N204078-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204078-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204078-002AP187673890dc5c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
6c2b16d0-96e9-444e-98c5-9883cd6eb72dProduct name220230316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ad279e69-d021-f6bd-1150-2b55f23832d5Product name920211014
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51754-1220-3Bloxiverz1 in 1 CARTONINJECTION118
51754-1220-3Bloxiverz10 in 1 PACKAGEINJECTION1018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-1220-3ML - Milliliter51754-1220dbb398ac-0352-4d70-829c-3418121dcbdd12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-1220BLOXIVERZ (NEOSTIGMINE METHYLSULFATE) INJECTION [EXELA PHARMA SCIENCES, LLC]18Legacy NDC, 2 package rows20240117_d2f55643-2b0d-4ef9-a9d8-b7138b314372.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BloxiverzNEOSTIGMINE METHYLSULFATEExela Pharma Sciences, LLCd2f55643-2b0d-4ef9-a9d8-b7138b3143722023-12-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 204078
application number: NDA204078
ndc (package): 51754-1220-3
ndc (product): 51754-1220
ndc11 (package): 51754122003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1429282Bloxiverz 0.5 MG/ML Injectable SolutionPSNd2f55643-2b0d-4ef9-a9d8-b7138b31437218
1429284Bloxiverz 1 MG/ML Injectable SolutionPSNd2f55643-2b0d-4ef9-a9d8-b7138b31437218
2673236Bloxiverz 5 MG in 5 ML Prefilled SyringePSNd2f55643-2b0d-4ef9-a9d8-b7138b31437218
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionPSNd2f55643-2b0d-4ef9-a9d8-b7138b31437218
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSNd2f55643-2b0d-4ef9-a9d8-b7138b31437218
1668225neostigmine methylsulfate 5 MG in 5 ML Prefilled SyringePSNd2f55643-2b0d-4ef9-a9d8-b7138b31437218
26732365 ML neostigmine methylsulfate 1 MG/ML Prefilled Syringe [Bloxiverz]SBDd2f55643-2b0d-4ef9-a9d8-b7138b31437218
1429282neostigmine methylsulfate 0.5 MG/ML Injectable Solution [Bloxiverz]SBDd2f55643-2b0d-4ef9-a9d8-b7138b31437218
1429284neostigmine methylsulfate 1 MG/ML Injectable Solution [Bloxiverz]SBDd2f55643-2b0d-4ef9-a9d8-b7138b31437218
16682255 ML neostigmine methylsulfate 1 MG/ML Prefilled SyringeSCDd2f55643-2b0d-4ef9-a9d8-b7138b31437218
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSCDd2f55643-2b0d-4ef9-a9d8-b7138b31437218
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCDd2f55643-2b0d-4ef9-a9d8-b7138b31437218
26732365 ML Bloxiverz 1 MG/ML Prefilled SyringeSYd2f55643-2b0d-4ef9-a9d8-b7138b31437218
1429282Bloxiverz 0.5 MG/ML Injectable SolutionSYd2f55643-2b0d-4ef9-a9d8-b7138b31437218
1429284Bloxiverz 1 MG/ML Injectable SolutionSYd2f55643-2b0d-4ef9-a9d8-b7138b31437218
2673236Bloxiverz 5 MG per 5 ML Prefilled SyringeSYd2f55643-2b0d-4ef9-a9d8-b7138b31437218
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSYd2f55643-2b0d-4ef9-a9d8-b7138b31437218
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSYd2f55643-2b0d-4ef9-a9d8-b7138b31437218
1668225neostigmine methylsulfate 5 MG per 5 ML Prefilled SyringeSYd2f55643-2b0d-4ef9-a9d8-b7138b31437218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51754-1220-35175412200310 CARTON in 1 PACKAGE (51754-1220-3) > 1 VIAL, MULTI-DOSE in 1 CARTON > 10 mL in 1 VIAL, MULTI-DOSE10 carton2013-07-240000-00-00NoNoCurrent