famotidine

Product NDC
83324-008
11-digit product format
833240008
Labeler code
83324
Product ID
83324-008_14a35301-b682-06ca-e063-6394a90a7bc6
Type
HUMAN OTC DRUG
Nonproprietary name
famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
ANDA215766
Marketing category
ANDA
Marketing start
2024-03-06
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
famotidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199047, 310273

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
83324-008-50famotidine50 in 1 CONTAINERTABLET, FILM COATED501
83324-008-50famotidine1 in 1 CARTONTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-008FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.]1Current NDC, 2 package rows20240328_6daf1ebe-b0a2-4413-bf25-3de6eb64b0c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN6daf1ebe-b0a2-4413-bf25-3de6eb64b0c61
310273famotidine 20 MG Oral TabletPSN6daf1ebe-b0a2-4413-bf25-3de6eb64b0c61
199047famotidine 10 MG Oral TabletSCD6daf1ebe-b0a2-4413-bf25-3de6eb64b0c61
310273famotidine 20 MG Oral TabletSCD6daf1ebe-b0a2-4413-bf25-3de6eb64b0c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-008-50833240008501 CONTAINER in 1 CARTON (83324-008-50) / 50 TABLET, FILM COATED in 1 CONTAINER1 container2024-03-06NoNoCurrent