Leader Acid Reducer

Product NDC
70000-0654
11-digit product format
700000654
Labeler code
70000
Product ID
70000-0654_563bca3a-1a43-4520-ac66-3aecd0d3c5fd
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA077351
Marketing category
ANDA
Marketing start
2024-01-25
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
Leader Acid Reducer
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
70000-0654-1Leader Acid Reducer1 in 1 CARTONTABLET, FILM COATED14
70000-0654-1Leader Acid Reducer50 in 1 BOTTLETABLET, FILM COATED504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0654LEADER ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, 2 package rows20250212_321b83f9-4bbf-494a-9279-80b0742049b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN321b83f9-4bbf-494a-9279-80b0742049b64
310273famotidine 20 MG Oral TabletSCD321b83f9-4bbf-494a-9279-80b0742049b64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0654-1700000654011 BOTTLE in 1 CARTON (70000-0654-1) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-25NoNoHistorical