FDA.reportPublic FDA data

Welmate Famotidine 10mg

Product NDC
73581-108
11-digit product format
735810108
Labeler code
73581
Product ID
73581-108_3b0b7c5c-9d4e-5cc4-e063-6294a90acecf
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine 10mg
Dosage form
TABLET
Route
ORAL
Labeler
YYBA Corp
Application
ANDA215822
Marketing category
ANDA
Marketing start
2024-07-25
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
Welmate Famotidine 10mg
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
73581-108-09Welmate Famotidine 10mg90 in 1 BOTTLETABLET902
73581-108-10Welmate Famotidine 10mg300 in 1 BOTTLETABLET3002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73581-108WELMATE FAMOTIDINE 10MG (FAMOTIDINE 10MG) TABLET [YYBA CORP]1Current NDC, 2 package rows20240727_1e19d0cc-65d7-8ec4-e063-6394a90a3d2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN1e19d0cc-65d7-8ec4-e063-6394a90a3d2a2
199047famotidine 10 MG Oral TabletSCD1e19d0cc-65d7-8ec4-e063-6394a90a3d2a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73581-108-097358101080990 TABLET in 1 BOTTLE (73581-108-09) 90 tablet2025-06-01NoNoCurrent
73581-108-1073581010810300 TABLET in 1 BOTTLE (73581-108-10) 300 tablet2024-07-25NoNoCurrent