Pyridostigmine

Product NDC
70954-148
11-digit product format
709540148
Labeler code
70954
Product ID
70954-148_ef78ff05-8e0f-463a-88cd-ca9a01aed76a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyridostigmine bromide oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Novitium Pharma LLC
Application
ANDA211694
Marketing category
ANDA
Marketing start
2019-03-11
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
60 mg/5mL
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
Pyridostigmine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRIDOSTIGMINE BROMIDE60 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKVI301NA53
Rxcui903843

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cd6f4a37-8abf-2ed8-817f-5becdfa53ca5Product name920230112
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
dd640b44-88ec-4cbe-02c0-23127b95f5d3Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-148-10Pyridostigmine473 mL in 1 BOTTLESOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-148-10ML - Milliliter70954-1486f5d15d6-d6ef-40b1-bb45-df3014f198cb12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-148PYRIDOSTIGMINE (PYRIDOSTIGMINE BROMIDE ORAL) SOLUTION [NOVITIUM PHARMA LLC]1Current NDC, Legacy NDC, 1 package rows20190321_ef78ff05-8e0f-463a-88cd-ca9a01aed76a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903843pyRIDostigmine bromide 60 MG in 5 mL Oral SolutionPSN9ab2ece0-7c0d-4045-a9f1-447aa97d623e6
903843pyridostigmine bromide 12 MG/ML Oral SolutionSCD9ab2ece0-7c0d-4045-a9f1-447aa97d623e6
903843pyridostigmine bromide 60 MG per 5 ML Oral SolutionSY9ab2ece0-7c0d-4045-a9f1-447aa97d623e6
903843pyRIDostigmine bromide 60 MG in 5 mL Oral SolutionPSNef78ff05-8e0f-463a-88cd-ca9a01aed76a1
903843pyridostigmine bromide 12 MG/ML Oral SolutionSCDef78ff05-8e0f-463a-88cd-ca9a01aed76a1
903843pyridostigmine bromide 60 MG per 5 ML Oral SolutionSYef78ff05-8e0f-463a-88cd-ca9a01aed76a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-148-1070954014810473 mL in 1 BOTTLE (70954-148-10) 473 ml2019-03-110000-00-00NoNoCurrent