FDA.reportPublic FDA data

Pyridostigmine Bromide

Product NDC
66689-406
11-digit product format
666890406
Labeler code
66689
Product ID
66689-406_31adc7e2-f149-4fb1-a7b9-4693a00d0246
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyridostigmine Bromide
Dosage form
SOLUTION
Route
ORAL
Labeler
VistaPharm, LLC
Application
ANDA211694
Marketing category
ANDA
Marketing start
2020-01-06
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
66689-406-102024-01-30C16284748780-11030e365-5dae-111a-e063-dadaa90a10e2Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL VistaPharm, Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66689-406-01Pyridostigmine Bromide5 mL in 1 CUP, UNIT-DOSESOLUTION56
66689-406-10Pyridostigmine Bromide10 in 1 TRAYSOLUTION106
66689-406-10Pyridostigmine Bromide1 in 1 CASESOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-406-01ML - Milliliter66689-40678abb452-631d-4682-8cd6-039a55a4c07212020-02-13
66689-406-10ML - Milliliter66689-406ed60c4eb-f0bb-4b09-816b-0d99c70b0f2112020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-406PYRIDOSTIGMINE BROMIDE SOLUTION [VISTAPHARM, LLC]5Current NDC, Legacy NDC, 3 package rows20240711_9ab2ece0-7c0d-4045-a9f1-447aa97d623e.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-406-01666890406015 mL in 1 CUP, UNIT-DOSE5 mlHistorical
66689-406-10666890406101 TRAY in 1 CASE (66689-406-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-406-01) 1 tray2020-01-060000-00-00NoNoCurrent