Pyridostigmine Bromide

Product NDC
72205-098
11-digit product format
722050098
Labeler code
72205
Product ID
72205-098_0bed477f-b228-4f8d-a956-f192b1329ea0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyridostigmine Bromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA216512
Marketing category
ANDA
Marketing start
2023-09-21
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
dd640b44-88ec-4cbe-02c0-23127b95f5d3Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-098-72Pyridostigmine Bromide473 mL in 1 BOTTLESOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-098-72ML - Milliliter72205-0989cf39b0f-3c65-42c4-8aa2-85227f214df412024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-098PYRIDOSTIGMINE BROMIDE SOLUTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 1 package rows20231006_0bed477f-b228-4f8d-a956-f192b1329ea0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903843pyRIDostigmine bromide 60 MG in 5 mL Oral SolutionPSN0bed477f-b228-4f8d-a956-f192b1329ea01
903843pyridostigmine bromide 12 MG/ML Oral SolutionSCD0bed477f-b228-4f8d-a956-f192b1329ea01
903843pyridostigmine bromide 60 MG per 5 ML Oral SolutionSY0bed477f-b228-4f8d-a956-f192b1329ea01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-098-7272205009872473 mL in 1 BOTTLE (72205-098-72) 473 ml2023-09-26NoNoCurrent