Pyridostigmine Bromide

Product NDC
62559-470
11-digit product format
625590470
Labeler code
62559
Product ID
62559-470_138c3e38-dc2d-46be-8ee6-bef9221a971c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyridostigmine Bromide
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA040512
Marketing category
ANDA
Marketing start
2024-01-16
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
60 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKVI301NA53
Rxcui903857

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cd6f4a37-8abf-2ed8-817f-5becdfa53ca5Product name920230112
dd640b44-88ec-4cbe-02c0-23127b95f5d3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-470-01Pyridostigmine Bromide100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-470-01EA - Each62559-4703fe6c2b9-2c77-4ab2-9441-811e3412d32f12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-470PYRIDOSTIGMINE BROMIDE TABLET [ANI PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20240117_0a114d99-e50b-49fe-9e0f-ccce279ffb4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903857pyRIDostigmine bromide 60 MG Oral TabletPSN0a114d99-e50b-49fe-9e0f-ccce279ffb4f3
903857pyridostigmine bromide 60 MG Oral TabletSCD0a114d99-e50b-49fe-9e0f-ccce279ffb4f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62559-470-0162559047001100 TABLET in 1 BOTTLE (62559-470-01) 100 tablet2024-01-16NoNoHistorical