Pyridostigmine Bromide

Product NDC
0115-2134
11-digit product format
001152134
Labeler code
0115
Product ID
0115-2134_83d6b85c-0cd0-467c-90aa-6998f5302559
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PYRIDOSTIGMINE BROMIDE
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040502
Marketing category
ANDA
Marketing start
2022-08-08
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
30 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 BROMIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKVI301NA53
Rxcui903841

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
0115-2134-01Pyridostigmine Bromide21 in 1 BOTTLETABLET212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-2134PYRIDOSTIGMINE BROMIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]2Current NDC, Legacy NDC, 1 package rows20240101_91ca7bcf-d2cc-4cb3-bfbe-c294fd707524.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903841pyRIDostigmine bromide 30 MG Oral TabletPSN91ca7bcf-d2cc-4cb3-bfbe-c294fd7075242
903841pyridostigmine bromide 30 MG Oral TabletSCD91ca7bcf-d2cc-4cb3-bfbe-c294fd7075242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-2134-010011521340121 TABLET in 1 BOTTLE (0115-2134-01) 21 tablet2022-08-080000-00-00NoNoCurrent