Famotidine

Product NDC
68788-8285
11-digit product format
687888285
Labeler code
68788
Product ID
68788-8285_95cca7ae-0224-4e48-a868-7e18f114ee88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216441
Marketing category
ANDA
Marketing start
2022-11-17
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8285-1EA - Each68788-8285b6633cff-b323-4f2a-94ce-f3cc2e653db812023-01-09
68788-8285-3EA - Each68788-82856e3d5c5f-c8cf-4799-8817-31f37856363012023-01-09
68788-8285-6EA - Each68788-8285b2c1784d-d043-4d25-a70c-61ed8b5b362712023-01-09
68788-8285-8EA - Each68788-8285fbd04ab5-eb52-40ac-b9b4-a9389588163c12023-01-09
68788-8285-9EA - Each68788-8285604b4bba-4144-47cb-a6dd-da333e24837012023-01-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8285-168788828501100 TABLET, FILM COATED in 1 BOTTLE (68788-8285-1) 2022-11-170000-00-00NoNoCurrent
68788-8285-36878882850330 TABLET, FILM COATED in 1 BOTTLE (68788-8285-3) 2022-11-170000-00-00NoNoCurrent
68788-8285-66878882850660 TABLET, FILM COATED in 1 BOTTLE (68788-8285-6) 2022-11-170000-00-00NoNoCurrent
68788-8285-868788828508120 TABLET, FILM COATED in 1 BOTTLE (68788-8285-8) 2022-11-170000-00-00NoNoCurrent
68788-8285-96878882850990 TABLET, FILM COATED in 1 BOTTLE (68788-8285-9) 2022-11-170000-00-00NoNoCurrent