FDA.reportPublic FDA data

BUSPIRONE HYDROCHLORIDE

Product NDC
82804-039
11-digit product format
828040039
Labeler code
82804
Product ID
82804-039_6760a11b-77e0-4c07-8a29-ac7e483a510d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUSPIRONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078246
Marketing category
ANDA
Marketing start
2020-02-21
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
7.5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUSPIRONE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866111

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9968269-ddf2-400e-9170-7376dcf3545aProduct name120251215
2cf3c2e9-d566-c982-009a-188fe4f776b9Product name820200428
4a9096ce-7b98-89e5-5942-15f48c4f7abfProduct name520190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-039-20BUSPIRONE HYDROCHLORIDE20 in 1 BOTTLETABLET202
82804-039-30BUSPIRONE HYDROCHLORIDE30 in 1 BOTTLETABLET302
82804-039-60BUSPIRONE HYDROCHLORIDE60 in 1 BOTTLETABLET602
82804-039-90BUSPIRONE HYDROCHLORIDE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-039-20EA - Each82804-039aedcada7-fb05-411e-97c7-f2c464a709c712024-04-05
82804-039-60EA - Each82804-039a8b0a2f4-bd57-480c-999c-7a8b6b72ac7712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-039BUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, 4 package rows20240310_75b1ae3f-e926-4555-a0e9-50323fc66cb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866111busPIRone HCl 7.5 MG Oral TabletPSN75b1ae3f-e926-4555-a0e9-50323fc66cb22
866111buspirone hydrochloride 7.5 MG Oral TabletSCD75b1ae3f-e926-4555-a0e9-50323fc66cb22
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY75b1ae3f-e926-4555-a0e9-50323fc66cb22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-039-208280400392020 TABLET in 1 BOTTLE (82804-039-20) 20 tablet2024-02-27NoNoCurrent
82804-039-308280400393030 TABLET in 1 BOTTLE (82804-039-30) 30 tablet2023-11-07NoNoCurrent
82804-039-608280400396060 TABLET in 1 BOTTLE (82804-039-60) 60 tablet2023-11-07NoNoCurrent
82804-039-908280400399090 TABLET in 1 BOTTLE (82804-039-90) 90 tablet2023-11-07NoNoCurrent