FDA.reportPublic FDA data

Bloxiverz

Product NDC
51754-1200
11-digit product format
517541200
Labeler code
51754
Product ID
51754-1200_f9ddedaa-a4a1-4fa2-8a3e-a3bb3abdde47
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
2023-11-06
Substance
NEOSTIGMINE METHYLSULFATE
Active strength
1 mg/mL
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOSTIGMINE METHYLSULFATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98IMH7M386
Rxcui311935, 311936, 1429282, 1429284, 1668225, 2673236

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
51754-1200-3Bloxiverz10 in 1 CARTONINJECTION1018
51754-1200-3Bloxiverz5 mL in 1 SYRINGE, PLASTICINJECTION518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-1200-3ML - Milliliter51754-120096535e8b-91f8-490c-97e1-57bf509286ae12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-1200BLOXIVERZ (NEOSTIGMINE METHYLSULFATE) INJECTION [EXELA PHARMA SCIENCES, LLC]18Current NDC, 2 package rows20240117_d2f55643-2b0d-4ef9-a9d8-b7138b314372.zip

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 formatDescriptionMarketing startSampleExclude flagStatus
51754-1200-35175412000310 SYRINGE, PLASTIC in 1 CARTON (51754-1200-3) / 5 mL in 1 SYRINGE, PLASTIC2023-12-31NoNoHistorical