Pyridostigmine Bromide

Product NDC
68084-494
11-digit product format
680840494
Labeler code
68084
Product ID
68084-494_386b22b2-6b00-f2c0-e063-6394a90a0d43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyridostigmine Bromide
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040502
Marketing category
ANDA
Marketing start
2011-10-04
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
68084-494-01Pyridostigmine Bromide100 in 1 BOX, UNIT-DOSETABLET10011
68084-494-11Pyridostigmine Bromide1 in 1 BLISTER PACKTABLET111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-494-01EA - Each68084-494eca0b284-14e5-4e50-ac73-adfcacb7f72d12012-07-24
68084-494-11EA - Each68084-49456176f96-4cf7-4ed7-a5d0-0f6356f664b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRIDOSTIGMINE BROMIDEACTIVE INGREDIENTKVI301NA53PYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]2
PYRIDOSTIGMINEACTIVE MOIETY19QM69HH21PYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-494PYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20241218_30cb0b9f-e308-4501-90c2-b17349c048b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903857pyRIDostigmine bromide 60 MG Oral TabletPSN30cb0b9f-e308-4501-90c2-b17349c048b711
903857pyridostigmine bromide 60 MG Oral TabletSCD30cb0b9f-e308-4501-90c2-b17349c048b711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-494-0168084049401100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-494-01) / 1 TABLET in 1 BLISTER PACK (68084-494-11) 100 blister pack2011-10-040000-00-00NoNoCurrent
68084-494-11680840494111 in 1 BLISTER PACKHistorical