FDA.reportPublic FDA data

neostigmine methylsulfate

Product NDC
71288-500
11-digit product format
712880500
Labeler code
71288
Product ID
71288-500_bf415978-8e01-4c77-e053-2995a90a9ea3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neostigmine methylsulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA212804
Marketing category
ANDA
Marketing start
2021-04-05
Substance
NEOSTIGMINE METHYLSULFATE
Active strength
.51 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
neostigmine methylsulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOSTIGMINE METHYLSULFATE.51 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98IMH7M386
Rxcui311935, 311936

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
71288-500-10neostigmine methylsulfate10 mL in 1 VIAL, MULTI-DOSEINJECTION103
71288-500-11neostigmine methylsulfate10 in 1 CARTONINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-500-10ML - Milliliter71288-500880516be-2a5a-4a24-85bf-5e7dec566e7412021-06-02
71288-500-11ML - Milliliter71288-500dbe9655d-8ee1-4615-b0d2-eba7dc59505612021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-500NEOSTIGMINE METHYLSULFATE INJECTION [MEITHEAL PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20210407_5a01a429-a346-4253-8994-b58d34b57974.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionPSN5a01a429-a346-4253-8994-b58d34b579743
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSN5a01a429-a346-4253-8994-b58d34b579743
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSCD5a01a429-a346-4253-8994-b58d34b579743
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCD5a01a429-a346-4253-8994-b58d34b579743
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSY5a01a429-a346-4253-8994-b58d34b579743
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSY5a01a429-a346-4253-8994-b58d34b579743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-500-107128805001010 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
71288-500-117128805001110 VIAL, MULTI-DOSE in 1 CARTON (71288-500-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-500-10) 2021-04-050000-00-00NoNoCurrent