FDA.reportPublic FDA data

ACID REDUCER

Product NDC
42507-194
11-digit product format
425070194
Labeler code
42507
Product ID
42507-194_b87aab55-018f-4b26-86ed-c733a5e756a5
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HyVee Inc
Application
ANDA077351
Marketing category
ANDA
Marketing start
2026-02-25
Substance
FAMOTIDINE
Active strength
20 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACID REDUCER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui310273

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-194-01ACID REDUCER25 in 1 CARTONTABLET, FILM COATED252
42507-194-01ACID REDUCER1 in 1 BLISTER PACKTABLET, FILM COATED12
42507-194-50ACID REDUCER50 in 1 BOTTLETABLET, FILM COATED502
42507-194-71ACID REDUCER1 in 1 CARTONTABLET, FILM COATED12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN381db08e-5756-4255-8202-1d8e6a1cf0382
310273famotidine 20 MG Oral TabletSCD381db08e-5756-4255-8202-1d8e6a1cf0382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-194-014250701940125 BLISTER PACK in 1 CARTON (42507-194-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2026-02-25NoNoHistorical
42507-194-504250701945050 in 1 BOTTLEHistorical
42507-194-71425070194711 BOTTLE in 1 CARTON (42507-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE (42507-194-50) 1 bottle2026-02-25NoNoHistorical