FDA.reportPublic FDA data

Neostigmine methylsulfate

Product NDC
70121-1479
11-digit product format
701211479
Labeler code
70121
Product ID
70121-1479_52f5f95d-6168-497d-bbb7-74889d1b2733
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neostigmine methylsulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210051
Marketing category
ANDA
Marketing start
2018-06-20
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
Neostigmine methylsulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOSTIGMINE METHYLSULFATE1 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
70121-1479-1Neostigmine methylsulfate10 mL in 1 VIAL, MULTI-DOSEINJECTION108
70121-1479-7Neostigmine methylsulfate10 in 1 CARTONINJECTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1479-1ML - Milliliter70121-14799c40ad9d-4a01-4cd4-b570-9cec972736ad12019-01-24
70121-1479-7ML - Milliliter70121-1479faf92b9f-05f7-4ec3-9afe-9556b636a6bd12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1479NEOSTIGMINE METHYLSULFATE INJECTION [AMNEAL PHARMACEUTICALS LLC]8Current NDC, Legacy NDC, 2 package rows20240831_856c3775-8925-4bd5-a93d-604829e73440.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionPSN856c3775-8925-4bd5-a93d-604829e734408
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSN856c3775-8925-4bd5-a93d-604829e734408
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSCD856c3775-8925-4bd5-a93d-604829e734408
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCD856c3775-8925-4bd5-a93d-604829e734408
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSY856c3775-8925-4bd5-a93d-604829e734408
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSY856c3775-8925-4bd5-a93d-604829e734408

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1479-17012114790110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
70121-1479-77012114790710 VIAL, MULTI-DOSE in 1 CARTON (70121-1479-7) / 10 mL in 1 VIAL, MULTI-DOSE (70121-1479-1) 2018-06-200000-00-00NoNoCurrent