Acid Reducer

Product NDC
85828-443
11-digit product format
858280443
Labeler code
85828
Product ID
85828-443_39e5e058-6419-4d47-ab41-d051f58065a1
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine 20mg
Dosage form
TABLET
Route
ORAL
Labeler
Grocery Outlet
Application
ANDA215822
Marketing category
ANDA
Marketing start
2026-03-20
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
Brand name suffix
Maximum Strength
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85828-443-25Acid ReducerMaximum Strength1 in 1 CARTONTABLET16
85828-443-25Acid ReducerMaximum Strength25 in 1 BOTTLETABLET256

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN0c85b203-3d09-4799-97a9-722ee207bbfb6
310273famotidine 20 MG Oral TabletSCD0c85b203-3d09-4799-97a9-722ee207bbfb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85828-443-25858280443251 BOTTLE in 1 CARTON (85828-443-25) / 25 TABLET in 1 BOTTLE1 bottle2026-03-20NoNoHistorical