FDA.reportPublic FDA data

basic care acid reducer

Product NDC
72288-194
11-digit product format
722880194
Labeler code
72288
Product ID
72288-194_c2571299-d298-49de-84b3-be58dd9451ec
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA077351
Marketing category
ANDA
Marketing start
2020-10-06
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
basic care 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
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
72288-194-00basic care acid reducer200 in 1 BOTTLETABLET, FILM COATED2004
72288-194-00basic care acid reducer2 in 1 CARTONTABLET, FILM COATED24
72288-194-02basic care acid reducer1 in 1 BLISTER PACKTABLET, FILM COATED14
72288-194-02basic care acid reducer25 in 1 CARTONTABLET, FILM COATED254
72288-194-71basic care acid reducer50 in 1 BOTTLETABLET, FILM COATED504
72288-194-71basic care acid reducer1 in 1 CARTONTABLET, FILM COATED14
72288-194-82basic care acid reducer200 in 1 BOTTLETABLET, FILM COATED2004
72288-194-82basic care acid reducer1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-194BASIC CARE ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [AMAZON.COM SERVICES LLC]4Current NDC, Legacy NDC, 8 package rows20250212_0983cef7-b8b6-4ed9-a01e-c699fa6d2d06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN0983cef7-b8b6-4ed9-a01e-c699fa6d2d064
310273famotidine 20 MG Oral TabletSCD0983cef7-b8b6-4ed9-a01e-c699fa6d2d064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-194-00722880194002 BOTTLE in 1 CARTON (72288-194-00) / 200 TABLET, FILM COATED in 1 BOTTLE2 bottle2022-04-110000-00-00NoNoCurrent
72288-194-027228801940225 BLISTER PACK in 1 CARTON (72288-194-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2021-07-090000-00-00NoNoCurrent
72288-194-71722880194711 BOTTLE in 1 CARTON (72288-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-310000-00-00NoNoCurrent
72288-194-82722880194821 BOTTLE in 1 CARTON (72288-194-82) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-10-060000-00-00NoNoCurrent