Pyridostigmine Bromide

Product NDC
58657-810
11-digit product format
586570810
Labeler code
58657
Product ID
58657-810_41b66d64-08b1-bd0c-e063-6394a90a5b86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PYRIDOSTIGMINE BROMIDE
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA211181
Marketing category
ANDA
Marketing start
2019-06-01
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
58657-810-10Pyridostigmine Bromide10 in 1 BLISTER PACKTABLET109
58657-810-10Pyridostigmine Bromide21 in 1 CARTONTABLET219
58657-810-21Pyridostigmine Bromide21 in 1 BOTTLETABLET219
58657-810-30Pyridostigmine Bromide30 in 1 CARTONTABLET309
58657-810-30Pyridostigmine Bromide3 in 1 CARTONTABLET39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-810-10EA - Each58657-8103f729235-2f08-4596-b6d8-e620879905e412020-06-05
58657-810-21EA - Each58657-8103afd0c04-5d77-473e-93c9-8cfeb0d139bf12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-810PYRIDOSTIGMINE BROMIDE TABLET [METHOD PHARMACEUTICALS, LLC]8Current NDC, Legacy NDC, 5 package rows20241126_e756717f-941b-42f2-ba3b-03798c005ae7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903841pyRIDostigmine bromide 30 MG Oral TabletPSNe756717f-941b-42f2-ba3b-03798c005ae79
903841pyridostigmine bromide 30 MG Oral TabletSCDe756717f-941b-42f2-ba3b-03798c005ae79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-810-105865708101021 BLISTER PACK in 1 CARTON (58657-810-10) > 10 TABLET in 1 BLISTER PACK21 blister pack2019-06-010000-00-00NoNoCurrent
58657-810-215865708102121 TABLET in 1 BOTTLE (58657-810-21) 21 tablet2019-06-010000-00-00NoNoCurrent
58657-810-305865708103030 CARTON in 1 CARTON (58657-810-30) > 3 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK30 carton2019-06-010000-00-00NoNoCurrent