Famotidine

Product NDC
49035-589
11-digit product format
490350589
Labeler code
49035
Product ID
49035-589_7c87bb9a-900d-48e3-9c09-8815aeff2504
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores, Inc.
Application
ANDA206531
Marketing category
ANDA
Marketing start
2020-06-24
Substance
FAMOTIDINE
Active strength
10 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
FAMOTIDINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199047

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
49035-589-19Famotidine90 in 1 BOTTLETABLET, FILM COATED907
49035-589-19Famotidine1 in 1 CARTONTABLET, FILM COATED17
49035-589-77Famotidine1 in 1 CARTONTABLET, FILM COATED17
49035-589-77Famotidine30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-589-77EA - Each49035-589564d294c-0daa-4216-8405-eb38891ccb9012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-589FAMOTIDINE TABLET, FILM COATED [WAL-MART STORES, INC.]7Current NDC, Legacy NDC, 4 package rows20250321_018b02e8-1005-4736-a4fc-962881f52adf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN018b02e8-1005-4736-a4fc-962881f52adf7
199047famotidine 10 MG Oral TabletSCD018b02e8-1005-4736-a4fc-962881f52adf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-589-19490350589191 BOTTLE in 1 CARTON (49035-589-19) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-06-240000-00-00NoNoCurrent
49035-589-77490350589771 BOTTLE in 1 CARTON (49035-589-77) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-01-210000-00-00NoNoCurrent