FDA.reportPublic FDA data

equaline heartburn prevention

Product NDC
41163-001
11-digit product format
411630001
Labeler code
41163
Product ID
41163-001_86987736-810a-4fda-93b9-2f62faf9e607
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA077351
Marketing category
ANDA
Marketing start
2014-12-05
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
equaline heartburn prevention
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
41163-001-02equaline heartburn prevention25 in 1 CARTONTABLET, FILM COATED259
41163-001-02equaline heartburn prevention1 in 1 BLISTER PACKTABLET, FILM COATED19
41163-001-51equaline heartburn prevention1 in 1 BLISTER PACKTABLET, FILM COATED19
41163-001-51equaline heartburn prevention8 in 1 CARTONTABLET, FILM COATED89
41163-001-71equaline heartburn prevention50 in 1 BOTTLETABLET, FILM COATED509
41163-001-71equaline heartburn prevention1 in 1 CARTONTABLET, FILM COATED19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-001EQUALINE HEARTBURN PREVENTION (FAMOTIDINE) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]8Current NDC, Legacy NDC, 6 package rows20250212_f40f1dcf-249a-4ccb-bdfc-acff49dd4a15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNf40f1dcf-249a-4ccb-bdfc-acff49dd4a159
310273famotidine 20 MG Oral TabletSCDf40f1dcf-249a-4ccb-bdfc-acff49dd4a159

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-001-024116300010225 BLISTER PACK in 1 CARTON (41163-001-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2014-12-170000-00-00NoNoCurrent
41163-001-51411630001511 in 1 BLISTER PACKHistorical
41163-001-71411630001711 BOTTLE in 1 CARTON (41163-001-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-12-170000-00-00NoNoCurrent