Famotidine

Product NDC
68645-594
11-digit product format
686450594
Labeler code
68645
Product ID
68645-594_4c22179c-cc92-d714-e063-6394a90a2d40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging, LLC
Application
ANDA075718
Marketing category
ANDA
Marketing start
2021-09-22
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
68645-594-59Famotidine60 in 1 BOTTLETABLET, FILM COATED6013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-594FAMOTIDINE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC]12Current NDC, Legacy NDC, 1 package rows20250313_cc88fbdc-546e-332f-e053-2995a90a8ca7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNcc88fbdc-546e-332f-e053-2995a90a8ca713
310273famotidine 20 MG Oral TabletSCDcc88fbdc-546e-332f-e053-2995a90a8ca713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68645-594-596864505945960 TABLET, FILM COATED in 1 BOTTLE (68645-594-59) 2021-09-220000-00-00NoNoCurrent