FDA.reportPublic FDA data

Buspirone hydrochloride

Product NDC
70518-1166
11-digit product format
705181166
Labeler code
70518
Product ID
70518-1166_6bf50bbb-6166-f931-e053-2991aa0a11f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078888
Marketing category
ANDA
Marketing start
2018-05-11
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1166-02020-05-19C16284748780-19d75b9d0-a9b7-f424-e053-dadaa90a57ceBuspirone Hydrochloride Tablets, USP
70518-1166-02020-01-31C16284748780-19d75b9d0-a9b7-f424-e053-dadaa90a57ceBuspirone Hydrochloride Tablets, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1166BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]4Legacy NDC20250507_a90c2dd6-3e95-407d-af05-ad2fbcc1fccd.zip