Quetiapine Fumarate

Product NDC
55700-903
11-digit product format
557000903
Labeler code
55700
Product ID
55700-903_beeae248-3022-4aaf-82fe-da862f31baf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA201504
Marketing category
ANDA
Marketing start
2021-03-18
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
100 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-903-30EA - Each55700-9033fcc2d89-9875-47fa-bd8b-875cd16beb3f12021-04-08
55700-903-90EA - Each55700-903c9a6b7a4-1287-4c5e-950b-4f7aae0e740412021-12-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-903-305570009033030 TABLET in 1 BOTTLE (55700-903-30) 30 tablet2021-03-180000-00-00NoNoCurrent
55700-903-905570009039090 TABLET in 1 BOTTLE (55700-903-90) 90 tablet2021-11-020000-00-00NoNoCurrent