Quetiapine Fumarate

Product NDC
55700-941
11-digit product format
557000941
Labeler code
55700
Product ID
55700-941_492156b9-74ee-46a2-9b97-22cadfdef3fd
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
2021-09-10
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
25 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
55700-941-30EA - Each55700-941c0f8508e-3ae5-4227-804c-b1ffe763935612021-10-08
55700-941-90EA - Each55700-9416175f327-7bff-4b41-b99b-78b52470486812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-941QUETIAPINE FUMARATE TABLET [QUALITY CARE PRODUCTS, LLC]5Legacy NDC20241220_fb4e8fe9-773f-45cc-9f67-3a668d16ce66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-941-305570009413030 TABLET in 1 BOTTLE (55700-941-30) 30 tablet2021-09-100000-00-00NoNoCurrent
55700-941-905570009419090 TABLET in 1 BOTTLE (55700-941-90) 90 tablet2021-11-020000-00-00NoNoCurrent