FDA.reportPublic FDA data

Pyridostigmine Bromide

Product NDC
69238-1731
11-digit product format
692381731
Labeler code
69238
Product ID
69238-1731_c11900df-97bb-47f5-8a29-05fe1586d556
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyridostigmine Bromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA212702
Marketing category
ANDA
Marketing start
2020-01-17
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69238-1731-22024-04-02C16284748780-1f386c64a-34b5-0266-e053-dadaa90a7c1aPyridostigmine Bromide Oral Solution, USP 60 mg/5 mL
69238-1731-22023-01-30C16284748780-1f386c64a-34b5-0266-e053-dadaa90a7c1aPyridostigmine Bromide Oral Solution, USP 60 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1731-2Pyridostigmine Bromide473 mL in 1 BOTTLESOLUTION4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1731-2ML - Milliliter69238-1731b1a09daf-2955-4acb-8174-66bb190b414e12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1731PYRIDOSTIGMINE BROMIDE SOLUTION [AMNEAL PHARMACEUTICALS NY LLC]8Current NDC, Legacy NDC, 1 package rows20240404_9c3a5abf-e217-4292-a305-5afd12b99e95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903843pyRIDostigmine bromide 60 MG in 5 mL Oral SolutionPSN9c3a5abf-e217-4292-a305-5afd12b99e958
903843pyridostigmine bromide 12 MG/ML Oral SolutionSCD9c3a5abf-e217-4292-a305-5afd12b99e958
903843pyridostigmine bromide 60 MG per 5 ML Oral SolutionSY9c3a5abf-e217-4292-a305-5afd12b99e958

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1731-269238173102473 mL in 1 BOTTLE (69238-1731-2) 473 ml2020-01-170000-00-00NoNoCurrent