FDA.reportPublic FDA data

Neostigmine methylsulfate

Product NDC
71839-105
11-digit product format
718390105
Labeler code
71839
Product ID
71839-105_a90a9fa9-dc93-4e87-94fa-e578918ccfce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neostigmine methylsulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BE Pharmaceuticals Inc.
Application
ANDA212512
Marketing category
ANDA
Marketing start
2019-05-13
Substance
NEOSTIGMINE METHYLSULFATE
Active strength
.5 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.5 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
71839-105-01Neostigmine methylsulfate10 mL in 1 VIAL, MULTI-DOSEINJECTION105
71839-105-01Neostigmine methylsulfate1 in 1 CARTONINJECTION15
71839-105-10Neostigmine methylsulfate10 mL in 1 VIAL, MULTI-DOSEINJECTION105
71839-105-10Neostigmine methylsulfate10 in 1 CARTONINJECTION105
71839-105-24Neostigmine methylsulfate24 in 1 CARTONINJECTION245

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71839-105-01ML - Milliliter71839-105d0cf1c05-8196-4a89-89d2-ba51563e4a0a12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71839-105NEOSTIGMINE METHYLSULFATE INJECTION [BE PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 5 package rows20220323_971713db-d5ac-44c1-ada5-a56a943d79bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionPSN971713db-d5ac-44c1-ada5-a56a943d79bf5
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSN971713db-d5ac-44c1-ada5-a56a943d79bf5
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSCD971713db-d5ac-44c1-ada5-a56a943d79bf5
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCD971713db-d5ac-44c1-ada5-a56a943d79bf5
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSY971713db-d5ac-44c1-ada5-a56a943d79bf5
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSY971713db-d5ac-44c1-ada5-a56a943d79bf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71839-105-017183901050110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
71839-105-107183901051010 VIAL, MULTI-DOSE in 1 CARTON (71839-105-10) / 10 mL in 1 VIAL, MULTI-DOSE2022-03-170000-00-00NoNoCurrent
71839-105-247183901052424 CARTON in 1 CARTON (71839-105-24) / 1 VIAL, MULTI-DOSE in 1 CARTON (71839-105-01) / 10 mL in 1 VIAL, MULTI-DOSE24 carton2019-05-130000-00-00NoNoCurrent