QUETIAPINE FUMARATE

Product NDC
70518-1841
11-digit product format
705181841
Labeler code
70518
Product ID
70518-1841_da33484f-f533-94bb-e053-2995a90a3f72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUETIAPINE FUMARATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090681
Marketing category
ANDA
Marketing start
2019-02-01
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
400 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1841QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]10Legacy NDC20250302_b6879670-a9d5-46d9-b18f-a34f0306c09a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1841-07051818410030 POUCH in 1 BOX, UNIT-DOSE (70518-1841-0) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-1841-1) 30 pouch2019-02-010000-00-00NoNoCurrent