FDA.reportPublic FDA data

Famotidine

Product NDC
49035-505
11-digit product format
490350505
Labeler code
49035
Product ID
49035-505_90ec3bbe-d56a-4536-a15a-3b577297fb1a
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
2016-04-26
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
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
49035-505-14Famotidine1 in 1 CARTONTABLET, FILM COATED111
49035-505-14Famotidine50 in 1 BOTTLETABLET, FILM COATED5011
49035-505-21Famotidine100 in 1 BOTTLETABLET, FILM COATED10011
49035-505-21Famotidine1 in 1 CARTONTABLET, FILM COATED111
49035-505-34Famotidine200 in 1 BOTTLETABLET, FILM COATED20011
49035-505-34Famotidine1 in 1 CARTONTABLET, FILM COATED111
49035-505-35Famotidine25 in 1 BOTTLETABLET, FILM COATED2511
49035-505-35Famotidine1 in 1 CARTONTABLET, FILM COATED111
49035-505-39Famotidine365 in 1 BOTTLETABLET, FILM COATED36511
49035-505-39Famotidine1 in 1 CARTONTABLET, FILM COATED111
49035-505-80Famotidine100 in 1 BOTTLETABLET, FILM COATED10011
49035-505-80Famotidine2 in 1 CARTONTABLET, FILM COATED211
49035-505-95Famotidine50 in 1 BOTTLETABLET, FILM COATED5011
49035-505-95Famotidine2 in 1 CARTONTABLET, FILM COATED211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-505-34EA - Each49035-505525c512a-775e-4db5-82c3-9fb4d0a9b9ba12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-505FAMOTIDINE TABLET, FILM COATED [WAL-MART STORES, INC.]11Current NDC, Legacy NDC, 14 package rows20250425_43fb44ea-07a1-4df9-8b4a-b2249757208e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN43fb44ea-07a1-4df9-8b4a-b2249757208e11
310273famotidine 20 MG Oral TabletSCD43fb44ea-07a1-4df9-8b4a-b2249757208e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-505-14490350505141 BOTTLE in 1 CARTON (49035-505-14) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-08-060000-00-00NoNoCurrent
49035-505-21490350505211 BOTTLE in 1 CARTON (49035-505-21) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-08-060000-00-00NoNoCurrent
49035-505-34490350505341 BOTTLE in 1 CARTON (49035-505-34) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-08-060000-00-00NoNoCurrent
49035-505-35490350505351 BOTTLE in 1 CARTON (49035-505-35) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
49035-505-39490350505391 BOTTLE in 1 CARTON (49035-505-39) / 365 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-01-210000-00-00NoNoCurrent
49035-505-80490350505802 BOTTLE in 1 CARTON (49035-505-80) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2020-08-060000-00-00NoNoCurrent
49035-505-95490350505952 BOTTLE in 1 CARTON (49035-505-95) / 50 TABLET, FILM COATED in 1 BOTTLE2 bottle2020-08-060000-00-00NoNoCurrent