Famotidine

Product NDC
0527-5190
11-digit product format
005275190
Labeler code
0527
Product ID
0527-5190_4aedf984-0009-404b-8c21-8af5f225f9db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA217982
Marketing category
ANDA
Marketing start
2025-06-02
Substance
FAMOTIDINE
Active strength
40 mg/5mL
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5QZO15J2Z8FAMOTIDINE76824-35-6FAMOTIDINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0527-5190-800052751908055 mL in 1 BOTTLE (0527-5190-80) 55 ml2025-06-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FamotidineLannett Company, Inc.2025-05-02HUMAN PRESCRIPTION DRUG LABEL6