HYDROXYCHLOROQUINE SULFATE

Product NDC
43598-132
11-digit product format
435980132
Labeler code
43598
Product ID
43598-132_45c22bbf-6332-4f7f-b77e-8ac613435821
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYCHLOROQUINE SULFATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA210441
Marketing category
ANDA
Marketing start
2022-10-24
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
300 mg/1
Pharmacologic classes
Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
8Q2869CNVHHYDROXYCHLOROQUINE SULFATE747-36-4HYDROXYCHLOROQUINE SULFATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-132-0143598013201100 TABLET, FILM COATED in 1 BOTTLE (43598-132-01) 2022-10-24NoNoHistorical
43598-132-0543598013205500 TABLET, FILM COATED in 1 BOTTLE (43598-132-05) 2022-10-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc. | Appco Pharma LLC | Axxelent Pharma2025-12-05Human Prescription Drug Label17
HYDROXYCHLOROQUINE SULFATEBryant Ranch Prepack2024-08-16HUMAN PRESCRIPTION DRUG LABEL1
HYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc. | Appco Pharma LLC2024-06-12Human Prescription Drug Label15