pyridostigmine bromide

Product NDC
68382-659
11-digit product format
683820659
Labeler code
68382
Product ID
68382-659_5439e6be-2d67-4bbd-b72f-3364cb62f907
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pyridostigmine bromide
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
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
68382-659-01pyridostigmine bromide100 in 1 BOTTLETABLET1004
68382-659-05pyridostigmine bromide500 in 1 BOTTLETABLET5004
68382-659-06pyridostigmine bromide30 in 1 BOTTLETABLET304
68382-659-16pyridostigmine bromide90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-659-01EA - Each68382-659b207ecc5-485f-4d37-9cb8-5c3bbab8db0b12015-09-10
68382-659-06EA - Each68382-659cd8936cc-2f71-45f8-92c3-b285dc8fe0d612017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRIDOSTIGMINE BROMIDEACTIVE INGREDIENTKVI301NA53PYRIDOSTIGMINE BROMIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
PYRIDOSTIGMINEACTIVE MOIETY19QM69HH21PYRIDOSTIGMINE BROMIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPYRIDOSTIGMINE BROMIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PYRIDOSTIGMINE BROMIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PYRIDOSTIGMINE BROMIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPYRIDOSTIGMINE BROMIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-659PYRIDOSTIGMINE BROMIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]4Current NDC, Legacy NDC, 4 package rows20231108_44e8c2dd-3931-4508-9fa7-5a660d6dfddb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903857pyRIDostigmine bromide 60 MG Oral TabletPSN36284496-e56e-466c-9b56-6007bb5bb6995
903857pyridostigmine bromide 60 MG Oral TabletSCD36284496-e56e-466c-9b56-6007bb5bb6995
903857pyRIDostigmine bromide 60 MG Oral TabletPSN44e8c2dd-3931-4508-9fa7-5a660d6dfddb4
903857pyridostigmine bromide 60 MG Oral TabletSCD44e8c2dd-3931-4508-9fa7-5a660d6dfddb4
903857pyRIDostigmine bromide 60 MG Oral TabletPSN235c6c04-3c09-0cf8-e063-6394a90a18461
903857pyridostigmine bromide 60 MG Oral TabletSCD235c6c04-3c09-0cf8-e063-6394a90a18461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-659-0168382065901100 TABLET in 1 BOTTLE (68382-659-01) 100 tablet2015-08-070000-00-00NoNoCurrent
68382-659-0568382065905500 TABLET in 1 BOTTLE (68382-659-05) 500 tablet2015-08-070000-00-00NoNoCurrent
68382-659-066838206590630 TABLET in 1 BOTTLE (68382-659-06) 30 tablet2015-08-070000-00-00NoNoCurrent
68382-659-166838206591690 TABLET in 1 BOTTLE (68382-659-16) 90 tablet2015-08-070000-00-00NoNoCurrent