Famotidine

Product NDC
70518-4395
11-digit product format
705184395
Labeler code
70518
Product ID
70518-4395_5033cd32-adb6-5ca4-e063-6294a90a16ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA217400
Marketing category
ANDA
Marketing start
2025-07-21
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine
Listing expiration
2027-12-31

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
70518-4395-0Famotidine30 in 1 BLISTER PACKTABLET, FILM COATED303
70518-4395-1Famotidine50 in 1 BOXTABLET, FILM COATED503
70518-4395-2Famotidine1 in 1 POUCHTABLET, FILM COATED13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN8dbf43e0-856f-443b-b8a4-c69e006878ea3
310273famotidine 20 MG Oral TabletSCD8dbf43e0-856f-443b-b8a4-c69e006878ea3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4395-07051843950030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4395-0) 2025-07-21NoNoHistorical
70518-4395-17051843950150 POUCH in 1 BOX (70518-4395-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-4395-2) 50 pouch2026-04-23NoNoHistorical
70518-4395-2705184395021 in 1 POUCHHistorical