FDA.reportPublic FDA data

Neostigmine Methylsulfate

Product NDC
23155-517
11-digit product format
231550517
Labeler code
23155
Product ID
23155-517_fe40568f-ed8b-43fe-987f-839427a5924f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neostigmine Methylsulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA208230
Marketing category
ANDA
Marketing start
2022-11-25
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
23155-517-31Neostigmine Methylsulfate10 mL in 1 VIALINJECTION108
23155-517-41Neostigmine Methylsulfate10 in 1 CARTONINJECTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-517-31ML - Milliliter23155-51763b0a965-bdaa-4b00-8489-e3d313940fe912024-07-12
23155-517-41ML - Milliliter23155-51777b6f635-0d57-4f64-ae62-e09f9e9bb7f612024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-517NEOSTIGMINE METHYLSULFATE INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20240620_9cc2bfa1-c968-4d01-8162-2ef188974164.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionPSN9cc2bfa1-c968-4d01-8162-2ef1889741648
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSN9cc2bfa1-c968-4d01-8162-2ef1889741648
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSCD9cc2bfa1-c968-4d01-8162-2ef1889741648
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCD9cc2bfa1-c968-4d01-8162-2ef1889741648
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSY9cc2bfa1-c968-4d01-8162-2ef1889741648
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSY9cc2bfa1-c968-4d01-8162-2ef1889741648

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-517-312315505173110 mL in 1 VIAL10 mlHistorical
23155-517-412315505174110 VIAL in 1 CARTON (23155-517-41) / 10 mL in 1 VIAL (23155-517-31) 10 vial2022-11-250000-00-00NoNoCurrent