FDA.reportPublic FDA data

Famotidine 20 mg

Product NDC
25000-124
11-digit product format
250000124
Labeler code
25000
Product ID
25000-124_1c69fac1-3052-45b1-ab46-a3b523347de1
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine 20 mg
Dosage form
TABLET, COATED
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA217543
Marketing category
ANDA
Marketing start
2025-05-23
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 20 mg
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
25000-124-68Famotidine 20 mg300 in 1 BOTTLETABLET, COATED3002
25000-124-84Famotidine 20 mg1 in 1 CARTONTABLET, COATED12
25000-124-84Famotidine 20 mg25 in 1 BOTTLETABLET, COATED252
25000-124-94Famotidine 20 mg5 in 1 BLISTER PACKTABLET, COATED52
25000-124-94Famotidine 20 mg5 in 1 CARTONTABLET, COATED52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-124FAMOTIDINE 20 MG TABLET, COATED [MARKSANS PHARMA LIMITED]2Current NDC, 5 package rows20250524_5a66206b-35b1-4d86-8574-a1e45cb0772f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN5a66206b-35b1-4d86-8574-a1e45cb0772f2
310273famotidine 20 MG Oral TabletSCD5a66206b-35b1-4d86-8574-a1e45cb0772f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25000-124-6825000012468300 TABLET, COATED in 1 BOTTLE (25000-124-68) 2025-05-23NoNoCurrent
25000-124-84250000124841 BOTTLE in 1 CARTON (25000-124-84) / 25 TABLET, COATED in 1 BOTTLE1 bottle2025-05-23NoNoCurrent
25000-124-94250000124945 BLISTER PACK in 1 CARTON (25000-124-94) / 5 TABLET, COATED in 1 BLISTER PACK5 blister pack2025-05-23NoNoCurrent