Famotidine

Product NDC
68788-8733
11-digit product format
687888733
Labeler code
68788
Product ID
68788-8733_9f00fdc6-548c-4d4e-ab25-d9196495f364
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA215767
Marketing category
ANDA
Marketing start
2024-09-16
Substance
FAMOTIDINE
Active strength
40 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
FAMOTIDINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui284245

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
68788-8733-3Famotidine30 in 1 BOTTLETABLET, FILM COATED303
68788-8733-4Famotidine14 in 1 BOTTLETABLET, FILM COATED143
68788-8733-6Famotidine60 in 1 BOTTLETABLET, FILM COATED603
68788-8733-9Famotidine90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8733-3EA - Each68788-8733b8adb916-41e9-4b93-85f0-6a606c4faeff12024-11-05
68788-8733-4EA - Each68788-8733d8d8ea3d-69dc-4c22-8a37-f055d8f3837112024-11-05
68788-8733-6EA - Each68788-87336ea586cc-7838-4ce7-8163-8b3339c30f2f12024-11-05
68788-8733-9EA - Each68788-87337a7f20ed-5679-4ef1-9500-432bb453896212024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8733FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20250511_b1edf3c5-e42c-471b-8771-6c93094822de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSNb1edf3c5-e42c-471b-8771-6c93094822de3
284245famotidine 40 MG Oral TabletSCDb1edf3c5-e42c-471b-8771-6c93094822de3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8733-36878887330330 TABLET, FILM COATED in 1 BOTTLE (68788-8733-3) 2024-09-16NoNoHistorical
68788-8733-46878887330414 TABLET, FILM COATED in 1 BOTTLE (68788-8733-4) 2024-09-16NoNoHistorical
68788-8733-66878887330660 TABLET, FILM COATED in 1 BOTTLE (68788-8733-6) 2024-09-16NoNoHistorical
68788-8733-96878887330990 TABLET, FILM COATED in 1 BOTTLE (68788-8733-9) 2024-09-16NoNoHistorical