pyridostigmine bromide

Product NDC
68682-307
11-digit product format
686820307
Labeler code
68682
Product ID
68682-307_dea0cb1f-7ec8-4f54-968f-8f095fa8ac95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pyridostigmine bromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
NDA015193
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-07-01
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
60 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKVI301NA53
Rxcui903843

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
68682-307-05pyridostigmine bromide473 mL in 1 BOTTLESOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-307-05ML - Milliliter68682-307d9fa53b5-e5d4-47c7-8c45-e0104fffaabb12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-307PYRIDOSTIGMINE BROMIDE SOLUTION [OCEANSIDE PHARMACEUTICALS]2Current NDC, Legacy NDC, 1 package rows20210212_970a0191-693c-480b-aeff-9f8956936159.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903843pyRIDostigmine bromide 60 MG in 5 mL Oral SolutionPSN970a0191-693c-480b-aeff-9f89569361592
903843pyridostigmine bromide 12 MG/ML Oral SolutionSCD970a0191-693c-480b-aeff-9f89569361592
903843pyridostigmine bromide 60 MG per 5 ML Oral SolutionSY970a0191-693c-480b-aeff-9f89569361592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-307-0568682030705473 mL in 1 BOTTLE (68682-307-05) 473 ml2019-07-010000-00-00NoNoCurrent