busPIRone HCl

Product NDC
69238-1116
11-digit product format
692381116
Labeler code
69238
Product ID
69238-1116_f697167a-4d7c-42fb-91c0-7c1f877bf54a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208829
Marketing category
ANDA
Marketing start
2017-05-24
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
8 mg/1
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
69238-1116-1EA - Each69238-111692c6b2bf-c1f4-44da-a965-3311cba4162912019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1116BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [AMNEAL PHARMACEUTICALS NY LLC]8Legacy NDC20241205_33999f17-f689-40a1-955a-fb19c0590e0e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1116-169238111601100 TABLET in 1 BOTTLE (69238-1116-1) 100 tablet2017-05-240000-00-00NoNoCurrent
69238-1116-569238111605500 TABLET in 1 BOTTLE (69238-1116-5) 500 tablet2017-05-240000-00-00NoNoCurrent