Pyridostigmine Bromide

Product NDC
42192-626
11-digit product format
421920626
Labeler code
42192
Product ID
42192-626_40422b8d-3f5d-6590-e063-6394a90a1532
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pyridostigmine bromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Acella Pharmaceuticals, LLC
Application
ANDA212405
Marketing category
ANDA
Marketing start
2023-10-09
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 Bromide
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
42192-626-16Pyridostigmine Bromide473 mL in 1 BOTTLESOLUTION4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-626PYRIDOSTIGMINE BROMIDE SOLUTION [ACELLA PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20241011_56999559-274e-44ea-a317-29366fdca908.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903843pyRIDostigmine bromide 60 MG in 5 mL Oral SolutionPSN56999559-274e-44ea-a317-29366fdca9083
903843pyridostigmine bromide 12 MG/ML Oral SolutionSCD56999559-274e-44ea-a317-29366fdca9083
903843pyridostigmine bromide 60 MG per 5 ML Oral SolutionSY56999559-274e-44ea-a317-29366fdca9083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42192-626-1642192062616473 mL in 1 BOTTLE (42192-626-16) 473 ml2023-10-09NoNoCurrent