FDA.reportPublic FDA data

AMAZON BASIC CARE ACID REDUCER

Product NDC
72288-363
11-digit product format
722880363
Labeler code
72288
Product ID
72288-363_48e68389-fd2a-42d7-baf2-55dc94eed23c
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA206531
Marketing category
ANDA
Marketing start
2024-05-15
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
AMAZON 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
72288-363-14AMAZON BASIC CARE ACID REDUCER1 in 1 CARTONTABLET, FILM COATED14
72288-363-14AMAZON BASIC CARE ACID REDUCER50 in 1 BOTTLETABLET, FILM COATED504
72288-363-34AMAZON BASIC CARE ACID REDUCER200 in 1 BOTTLETABLET, FILM COATED2004
72288-363-34AMAZON BASIC CARE ACID REDUCER1 in 1 CARTONTABLET, FILM COATED14
72288-363-40AMAZON BASIC CARE ACID REDUCER2 in 1 CARTONTABLET, FILM COATED24
72288-363-40AMAZON BASIC CARE ACID REDUCER200 in 1 BOTTLETABLET, FILM COATED2004
72288-363-53AMAZON BASIC CARE ACID REDUCER1 in 1 CARTONTABLET, FILM COATED14
72288-363-53AMAZON BASIC CARE ACID REDUCER25 in 1 BOTTLETABLET, FILM COATED254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-363AMAZON BASIC CARE ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [AMAZON.COM SERVICES LLC]4Current NDC, 8 package rows20250425_10ed726b-9792-4d8d-e063-6294a90ae61d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN10ed726b-9792-4d8d-e063-6294a90ae61d4
310273famotidine 20 MG Oral TabletSCD10ed726b-9792-4d8d-e063-6294a90ae61d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-363-14722880363141 BOTTLE in 1 CARTON (72288-363-14) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-363-34722880363341 BOTTLE in 1 CARTON (72288-363-34) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-363-40722880363402 BOTTLE in 1 CARTON (72288-363-40) / 200 TABLET, FILM COATED in 1 BOTTLE2 bottle2024-05-15NoNoCurrent
72288-363-53722880363531 BOTTLE in 1 CARTON (72288-363-53) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-15NoNoCurrent