Quetiapine Fumarate

Product NDC
51407-077
11-digit product format
514070077
Labeler code
51407
Product ID
51407-077_a2b7d516-721c-608d-e053-2995a90adbee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply
Application
ANDA208947
Marketing category
ANDA
Marketing start
2017-11-29
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-077-60EA - Each51407-07716d30b7e-323f-4244-b6dc-dcd1eaa71e2912018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-077QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]8Legacy NDC20241228_7b2218ae-a310-22d0-e053-2a91aa0a769d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-077-605140700776060 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-077-60) 2017-11-290000-00-00NoNoCurrent