Famotidine

Product NDC
68788-8889
11-digit product format
687888889
Labeler code
68788
Product ID
68788-8889_5ed77259-5dd9-4634-a073-346693488c4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075718
Marketing category
ANDA
Marketing start
2025-09-23
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
68788-8889-1Famotidine100 in 1 BOTTLETABLET, FILM COATED1001
68788-8889-3Famotidine30 in 1 BOTTLETABLET, FILM COATED301
68788-8889-6Famotidine60 in 1 BOTTLETABLET, FILM COATED601
68788-8889-9Famotidine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8889-3EA - Each68788-88896b112d5f-bdaf-46cb-a2e2-4a998e51f0bc12025-10-14
68788-8889-6EA - Each68788-88895c6149f8-7324-4fd2-98df-272852176a2612025-10-14
68788-8889-9EA - Each68788-8889bff4be8a-e5cb-401d-a705-ac6ed9c4396512025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN5ed77259-5dd9-4634-a073-346693488c4f1
310273famotidine 20 MG Oral TabletSCD5ed77259-5dd9-4634-a073-346693488c4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8889-168788888901100 TABLET, FILM COATED in 1 BOTTLE (68788-8889-1) 2025-09-23NoNoHistorical
68788-8889-36878888890330 TABLET, FILM COATED in 1 BOTTLE (68788-8889-3) 2025-09-23NoNoHistorical
68788-8889-66878888890660 TABLET, FILM COATED in 1 BOTTLE (68788-8889-6) 2025-09-23NoNoHistorical
68788-8889-96878888890990 TABLET, FILM COATED in 1 BOTTLE (68788-8889-9) 2025-09-23NoNoHistorical