FDA.reportPublic FDA data

Diurex

Product NDC
52389-249
11-digit product format
523890249
Labeler code
52389
Product ID
52389-249_3287c676-c9cc-273e-e063-6294a90a9c9b
Type
HUMAN OTC DRUG
Nonproprietary name
Pamabrom
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kobayashi Healthcare International, Inc.
Application
M027
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-12-20
Substance
PAMABROM
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diurex
Brand name suffix
Max
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAMABROM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUA8U0KJM72
Rxcui199158

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-249-10DiurexMax4 in 1 CARTONTABLET, FILM COATED414
52389-249-10DiurexMax10 in 1 BLISTER PACKTABLET, FILM COATED1014
52389-249-16DiurexMax2 in 1 CARTONTABLET, FILM COATED214
52389-249-16DiurexMax8 in 1 BLISTER PACKTABLET, FILM COATED814
52389-249-20DiurexMax30 in 1 BLISTER PACKTABLET, FILM COATED3014
52389-249-20DiurexMax1 in 1 CARTONTABLET, FILM COATED114
52389-249-24DiurexMax1 in 1 CARTONTABLET, FILM COATED114
52389-249-24DiurexMax24 in 1 BLISTER PACKTABLET, FILM COATED2414
52389-249-30DiurexMax10 in 1 BLISTER PACKTABLET, FILM COATED1014
52389-249-30DiurexMax3 in 1 CARTONTABLET, FILM COATED314
52389-249-40DiurexMax1 in 1 CARTONTABLET, FILM COATED114
52389-249-40DiurexMax40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4014
52389-249-48DiurexMax24 in 1 BLISTER PACKTABLET, FILM COATED2414
52389-249-48DiurexMax2 in 1 CARTONTABLET, FILM COATED214
52389-249-50DiurexMax10 in 1 BLISTER PACKTABLET, FILM COATED1014
52389-249-50DiurexMax5 in 1 CARTONTABLET, FILM COATED514
52389-249-72DiurexMax3 in 1 CARTONTABLET, FILM COATED314
52389-249-72DiurexMax24 in 1 BLISTER PACKTABLET, FILM COATED2414

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PamabromACTIVE INGREDIENTUA8U0KJM72DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
PamabromACTIVE MOIETYUA8U0KJM72DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Calcium sulfate dihydrateINACTIVE INGREDIENT4846Q921YMDIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPDIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
HypromelloseINACTIVE INGREDIENT3NXW29V3WODIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Magnesium stearateINACTIVE INGREDIENT70097M6I30DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Mineral oilINACTIVE INGREDIENTT5L8T28FGPDIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQDIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Potassium gluconateINACTIVE INGREDIENT12H3K5QKN9DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
RiboflavinINACTIVE INGREDIENTTLM2976OFRDIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Stearic acidINACTIVE INGREDIENT4ELV7Z65APDIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-249DIUREX MAX (PAMABROM) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]14Current NDC, Legacy NDC, 18 package rows20250413_37dfece3-d570-4ab2-ba95-af6eb1f3acd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199158pamabrom 50 MG Oral TabletPSN37dfece3-d570-4ab2-ba95-af6eb1f3acd414
199158pamabrom 50 MG Oral TabletSCD37dfece3-d570-4ab2-ba95-af6eb1f3acd414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52389-249-10523890249104 BLISTER PACK in 1 CARTON (52389-249-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2017-11-100000-00-00NoNoCurrent
52389-249-16523890249162 in 1 CARTONHistorical
52389-249-205238902492030 in 1 BLISTER PACKHistorical
52389-249-24523890249241 BLISTER PACK in 1 CARTON (52389-249-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2011-04-180000-00-00NoNoCurrent
52389-249-30523890249303 BLISTER PACK in 1 CARTON (52389-249-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2021-07-120000-00-00NoNoCurrent
52389-249-40523890249401 in 1 CARTONHistorical
52389-249-48523890249482 BLISTER PACK in 1 CARTON (52389-249-48) / 24 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2013-07-180000-00-00NoNoCurrent
52389-249-50523890249505 BLISTER PACK in 1 CARTON (52389-249-50) / 10 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2022-07-180000-00-00NoNoCurrent
52389-249-72523890249723 BLISTER PACK in 1 CARTON (52389-249-72) / 24 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2018-06-120000-00-00NoNoCurrent