FDA.reportPublic FDA data

Pyridostigmine Bromide

Product NDC
72458-128
11-digit product format
724580128
Labeler code
72458
Product ID
72458-128_96f61532-26f7-4143-80f4-e62133499d21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyridostigmine Bromide
Dosage form
TABLET
Route
ORAL
Labeler
Surgeon General-Department of the Army (TSG-DA)
Application
NDA020414
Marketing category
NDA
Marketing start
1990-12-05
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
30 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pyridostigmine Bromide
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72458-128-022024-01-18C16284748780-1f386c649-9bda-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PYRIDOSTIGMINE BROMIDE TABLETS safely and effectively. See full prescribing information for PYRIDOSTIGMINE BROMIDE TABLETS . PYRIDOSTIGMINE BROMIDE tablets, for oral use Initial U.S. Approval: 1955
72458-128-042024-01-18C16284748780-1f386c649-9bda-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PYRIDOSTIGMINE BROMIDE TABLETS safely and effectively. See full prescribing information for PYRIDOSTIGMINE BROMIDE TABLETS . PYRIDOSTIGMINE BROMIDE tablets, for oral use Initial U.S. Approval: 1955
72458-128-022023-01-30C16284748780-1f386c649-9bda-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PYRIDOSTIGMINE BROMIDE TABLETS safely and effectively. See full prescribing information for PYRIDOSTIGMINE BROMIDE TABLETS . PYRIDOSTIGMINE BROMIDE tablets, for oral use Initial U.S. Approval: 1955
72458-128-042023-01-30C16284748780-1f386c649-9bda-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PYRIDOSTIGMINE BROMIDE TABLETS safely and effectively. See full prescribing information for PYRIDOSTIGMINE BROMIDE TABLETS . PYRIDOSTIGMINE BROMIDE tablets, for oral use Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72458-128-01Pyridostigmine Bromide21 in 1 BLISTER PACKTABLET216
72458-128-02Pyridostigmine Bromide10 in 1 BAGTABLET106
72458-128-03Pyridostigmine Bromide21 in 1 BLISTER PACKTABLET216
72458-128-04Pyridostigmine Bromide10 in 1 BAGTABLET106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72458-128PYRIDOSTIGMINE BROMIDE TABLET [SURGEON GENERAL-DEPARTMENT OF THE ARMY (TSG-DA)]5Current NDC, Legacy NDC, 4 package rows20241025_0b296555-c32f-42db-b5f3-ea981a3dd2f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903841pyRIDostigmine bromide 30 MG Oral TabletPSN0b296555-c32f-42db-b5f3-ea981a3dd2f86
903841pyridostigmine bromide 30 MG Oral TabletSCD0b296555-c32f-42db-b5f3-ea981a3dd2f86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72458-128-017245801280121 in 1 BLISTER PACKHistorical
72458-128-027245801280210 BLISTER PACK in 1 BAG (72458-128-02) / 21 TABLET in 1 BLISTER PACK (72458-128-01) 10 blister pack1990-12-050000-00-00NoNoCurrent
72458-128-037245801280321 in 1 BLISTER PACKHistorical
72458-128-047245801280410 BLISTER PACK in 1 BAG (72458-128-04) / 21 TABLET in 1 BLISTER PACK (72458-128-03) 10 blister pack2017-07-140000-00-00NoNoCurrent