FDA.reportPublic FDA data

Acid Reducer

Product NDC
69168-443
11-digit product format
691680443
Labeler code
69168
Product ID
69168-443_10efebb0-5d63-4c46-8934-9e91b213a543
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA215822
Marketing category
ANDA
Marketing start
2024-01-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acid Reducer
Listing expiration
2026-12-31

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
69168-443-09Acid Reducer10 in 1 BLISTER PACKTABLET105
69168-443-32Acid Reducer100 in 1 BOTTLETABLET1005
69168-443-50Acid Reducer1 in 1 CARTONTABLET15
69168-443-50Acid Reducer50 in 1 BOTTLETABLET505
69168-443-52Acid Reducer225 in 1 BOTTLETABLET2255
69168-443-99Acid Reducer365 in 1 BOTTLETABLET3655

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-443ACID REDUCER MAXIMUM STRENGTH (FAMOTODINE) TABLET [ALLEGIANT HEALTH]4Current NDC, 6 package rows20241030_adc2721d-2ca7-4a47-bae1-be298fa1c155.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNadc2721d-2ca7-4a47-bae1-be298fa1c1555
310273famotidine 20 MG Oral TabletSCDadc2721d-2ca7-4a47-bae1-be298fa1c1555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-443-096916804430910 TABLET in 1 BLISTER PACK (69168-443-09) 10 tablet2024-02-29NoNoCurrent
69168-443-3269168044332100 TABLET in 1 BOTTLE (69168-443-32) 100 tablet2024-01-15NoNoCurrent
69168-443-50691680443501 BOTTLE in 1 CARTON (69168-443-50) / 50 TABLET in 1 BOTTLE1 bottle2024-03-05NoNoCurrent
69168-443-5269168044352225 TABLET in 1 BOTTLE (69168-443-52) 225 tablet2024-01-15NoNoCurrent
69168-443-9969168044399365 TABLET in 1 BOTTLE (69168-443-99) 365 tablet2024-10-28NoNoCurrent