Quetiapine Fumarate

Product NDC
70518-2702
11-digit product format
705182702
Labeler code
70518
Product ID
70518-2702_ccff1f3b-ceb1-6d86-e053-2995a90a7ac3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206260
Marketing category
ANDA
Marketing start
2020-04-20
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2702-02023-03-13C16284748780-1f386c64a-24fd-0266-e053-dadaa90a7c1ac5e3eea5-0319-4697-9869-27b5d2994e3e
70518-2702-02023-01-30C16284748780-1f386c64a-24fd-0266-e053-dadaa90a7c1ac5e3eea5-0319-4697-9869-27b5d2994e3e

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2702-07051827020030 POUCH in 1 BOX (70518-2702-0) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-2702-1) 30 pouch2020-04-200000-00-00NoNoCurrent