FDA.reportPublic FDA data

FAMOTIDINE

Product NDC
70518-3829
11-digit product format
705183829
Labeler code
70518
Product ID
70518-3829_4131acc0-1b7a-ff93-e063-6294a90a1c23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA215630
Marketing category
ANDA
Marketing start
2023-08-15
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
70518-3829-0FAMOTIDINE50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5013
70518-3829-1FAMOTIDINE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3013
70518-3829-2FAMOTIDINE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6013
70518-3829-3FAMOTIDINE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013
70518-3829-4FAMOTIDINE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013
70518-3829-5FAMOTIDINE30 in 1 BLISTER PACKTABLET, FILM COATED3013
70518-3829-6FAMOTIDINE14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1413
70518-3829-7FAMOTIDINE60 in 1 BLISTER PACKTABLET, FILM COATED6013
70518-3829-8FAMOTIDINE14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1413
70518-3829-9FAMOTIDINE25 in 1 BOTTLE, PLASTICTABLET, FILM COATED2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3829FAMOTIDINE TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, 10 package rows20250115_e59a2c97-19c7-485c-bb1b-272ddb9ae053.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNe59a2c97-19c7-485c-bb1b-272ddb9ae05313
310273famotidine 20 MG Oral TabletSCDe59a2c97-19c7-485c-bb1b-272ddb9ae05313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3829-07051838290050 in 1 BOTTLE, PLASTICHistorical
70518-3829-17051838290130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-1) 2023-11-06NoNoHistorical
70518-3829-27051838290260 in 1 BOTTLE, PLASTICHistorical
70518-3829-37051838290390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-3) 2024-01-24NoNoHistorical
70518-3829-47051838290490 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-4) 2024-02-28NoNoHistorical
70518-3829-57051838290530 TABLET, FILM COATED in 1 BLISTER PACK (70518-3829-5) 2024-06-12NoNoHistorical
70518-3829-67051838290614 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-6) 2024-11-21NoNoHistorical
70518-3829-77051838290760 TABLET, FILM COATED in 1 BLISTER PACK (70518-3829-7) 2025-01-04NoNoHistorical
70518-3829-87051838290814 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-8) 2025-01-14NoNoHistorical
70518-3829-97051838290925 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-9) 2025-10-15NoNoHistorical