Pyridostigmine Bromide

Product NDC
47781-335
11-digit product format
477810335
Labeler code
47781
Product ID
47781-335_0429e410-7623-2f45-6170-d4a2eadd8742
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyridostigmine Bromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alvogen, Inc.
Application
ANDA204737
Marketing category
ANDA
Marketing start
2015-06-29
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
180 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 BROMIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKVI301NA53
Rxcui903847

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
47781-335-30Pyridostigmine Bromide30 in 1 BOTTLETABLET, EXTENDED RELEASE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-335-30EA - Each47781-3356faebc23-9a38-41d4-95c5-b56ac49636e012015-07-20

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-335PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [ALVOGEN, INC.]12Current NDC, Legacy NDC, 1 package rows20241012_93454159-0c58-1980-34b9-4038a2260420.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903847pyRIDostigmine bromide 180 MG Extended Release Oral TabletPSN93454159-0c58-1980-34b9-4038a226042014
903847pyridostigmine bromide 180 MG Extended Release Oral TabletSCD93454159-0c58-1980-34b9-4038a226042014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-335-304778103353030 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-335-30) 2015-06-290000-00-00NoNoCurrent