CIMETIDINE

Product NDC
59651-823
11-digit product format
596510823
Labeler code
59651
Product ID
59651-823_ebd53065-c080-4045-a398-64d3f3b1460f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIMETIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218997
Marketing category
ANDA
Marketing start
2024-11-12
Substance
CIMETIDINE
Active strength
200 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
80061L1WGDCIMETIDINE51481-61-9CIMETIDINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-823-0159651082301100 TABLET, FILM COATED in 1 BOTTLE (59651-823-01) 2024-11-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cimetidine Tablets, USP Rx onlyAurobindo Pharma Limited | APL HEALTHCARE LIMITED2024-11-14Human Prescription Drug Label1