FDA.reportPublic FDA data

ACID REDUCER

Product NDC
51316-511
11-digit product format
513160511
Labeler code
51316
Product ID
51316-511_59ec6c2c-f06f-458c-9dc5-1c9741569d86
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
ANDA077351
Marketing category
ANDA
Marketing start
2026-04-13
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
51316-511-63ACID REDUCER1 in 1 CARTONTABLET, FILM COATED13
51316-511-63ACID REDUCER25 in 1 BOTTLETABLET, FILM COATED253
51316-511-71ACID REDUCER50 in 1 BOTTLETABLET, FILM COATED503
51316-511-71ACID REDUCER1 in 1 CARTONTABLET, FILM COATED13
51316-511-78ACID REDUCER100 in 1 BOTTLETABLET, FILM COATED1003
51316-511-78ACID REDUCER1 in 1 CARTONTABLET, FILM COATED13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNf347f870-1da4-4a77-8c20-63b703d240713
310273famotidine 20 MG Oral TabletSCDf347f870-1da4-4a77-8c20-63b703d240713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-511-63513160511631 BOTTLE in 1 CARTON (51316-511-63) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2026-04-13NoNoHistorical
51316-511-71513160511711 BOTTLE in 1 CARTON (51316-511-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2026-04-20NoNoHistorical
51316-511-78513160511781 BOTTLE in 1 CARTON (51316-511-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2026-04-22NoNoHistorical