Acid Reducer

Product NDC
69168-445
11-digit product format
691680445
Labeler code
69168
Product ID
69168-445_8b9d16df-e73f-45e1-b5f9-3dfaa8c4b5f7
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA215767
Marketing category
ANDA
Marketing start
2024-10-31
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
69168-445-32Acid Reducer100 in 1 BOTTLETABLET1004
69168-445-52Acid Reducer225 in 1 BOTTLETABLET2254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-445ACID REDUCER MAXIMUM STRENGTH (FAMOTODINE) TABLET [ALLEGIANT HEALTH]3Current NDC, 2 package rows20241101_5c6c6665-cb0a-41d1-af28-85b4f061bd1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN5c6c6665-cb0a-41d1-af28-85b4f061bd1b4
310273famotidine 20 MG Oral TabletSCD5c6c6665-cb0a-41d1-af28-85b4f061bd1b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-445-3269168044532100 TABLET in 1 BOTTLE (69168-445-32) 100 tablet2024-10-31NoNoCurrent
69168-445-5269168044552225 TABLET in 1 BOTTLE (69168-445-52) 225 tablet2024-10-31NoNoCurrent