pyridostigmine bromide

Product NDC
65841-819
11-digit product format
658410819
Labeler code
65841
Product ID
65841-819_4f18b45a-d2c9-49d8-ad9e-245c8011615d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pyridostigmine bromide
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA205650
Marketing category
ANDA
Marketing start
2015-08-07
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
65841-819-01pyridostigmine bromide100 in 1 BOTTLETABLET1004
65841-819-05pyridostigmine bromide500 in 1 BOTTLETABLET5004
65841-819-06pyridostigmine bromide30 in 1 BOTTLETABLET304
65841-819-16pyridostigmine bromide90 in 1 BOTTLETABLET904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRIDOSTIGMINE BROMIDEACTIVE INGREDIENTKVI301NA53PYRIDOSTIGMINE BROMIDE TABLET [CADILA HEALTHCARE LIMITED]1
PYRIDOSTIGMINEACTIVE MOIETY19QM69HH21PYRIDOSTIGMINE BROMIDE TABLET [CADILA HEALTHCARE LIMITED]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPYRIDOSTIGMINE BROMIDE TABLET [CADILA HEALTHCARE LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PYRIDOSTIGMINE BROMIDE TABLET [CADILA HEALTHCARE LIMITED]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PYRIDOSTIGMINE BROMIDE TABLET [CADILA HEALTHCARE LIMITED]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPYRIDOSTIGMINE BROMIDE TABLET [CADILA HEALTHCARE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-819PYRIDOSTIGMINE BROMIDE TABLET [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 4 package rows20231108_ea4f753f-41a0-4f82-932c-181883d4b6d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903857pyRIDostigmine bromide 60 MG Oral TabletPSNea4f753f-41a0-4f82-932c-181883d4b6d34
903857pyridostigmine bromide 60 MG Oral TabletSCDea4f753f-41a0-4f82-932c-181883d4b6d34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-819-0165841081901100 TABLET in 1 BOTTLE (65841-819-01) 100 tablet2015-08-070000-00-00NoNoCurrent
65841-819-0565841081905500 TABLET in 1 BOTTLE (65841-819-05) 500 tablet2015-08-070000-00-00NoNoCurrent
65841-819-066584108190630 TABLET in 1 BOTTLE (65841-819-06) 30 tablet2015-08-070000-00-00NoNoCurrent
65841-819-166584108191690 TABLET in 1 BOTTLE (65841-819-16) 90 tablet2015-08-070000-00-00NoNoCurrent