FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
29300-244
11-digit product format
293000244
Labeler code
29300
Product ID
29300-244_ef78a61a-865b-447a-9324-3044e41db506
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2019-11-14
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866090, 866094

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
29300-244-01Buspirone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1007
29300-244-05Buspirone Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-244-01EA - Each29300-244260def47-f3ab-412c-8931-1554f077188512020-02-13
29300-244-05EA - Each29300-2448329d9bd-4da9-4cff-a723-24786eef587b12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-244BUSPIRONE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7Current NDC, Legacy NDC, 2 package rows20231223_a6bdf140-075e-445e-a62d-633a4b97f3a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSNeab53fff-c052-4466-a673-3d68aab98c27103
866094buspirone hydrochloride 5 MG Oral TabletSCDeab53fff-c052-4466-a673-3d68aab98c27103
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYeab53fff-c052-4466-a673-3d68aab98c27103
866083busPIRone HCl 10 MG Oral TabletPSNa6bdf140-075e-445e-a62d-633a4b97f3a87
866018busPIRone HCl 15 MG Oral TabletPSNa6bdf140-075e-445e-a62d-633a4b97f3a87
866090busPIRone HCl 30 MG Oral TabletPSNa6bdf140-075e-445e-a62d-633a4b97f3a87
866094busPIRone HCl 5 MG Oral TabletPSNa6bdf140-075e-445e-a62d-633a4b97f3a87
866094busPIRone HCl 5 MG Oral TabletPSN932422a8-b72c-4dab-b942-2ab092ed6b017
866094busPIRone HCl 5 MG Oral TabletPSN5b4da3f8-a5ce-4699-92e1-37fb95e0af2d7
866083buspirone hydrochloride 10 MG Oral TabletSCDa6bdf140-075e-445e-a62d-633a4b97f3a87
866018buspirone hydrochloride 15 MG Oral TabletSCDa6bdf140-075e-445e-a62d-633a4b97f3a87
866090buspirone hydrochloride 30 MG Oral TabletSCDa6bdf140-075e-445e-a62d-633a4b97f3a87
866094buspirone hydrochloride 5 MG Oral TabletSCD5b4da3f8-a5ce-4699-92e1-37fb95e0af2d7
866094buspirone hydrochloride 5 MG Oral TabletSCD932422a8-b72c-4dab-b942-2ab092ed6b017
866094buspirone hydrochloride 5 MG Oral TabletSCDa6bdf140-075e-445e-a62d-633a4b97f3a87
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYa6bdf140-075e-445e-a62d-633a4b97f3a87
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYa6bdf140-075e-445e-a62d-633a4b97f3a87
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYa6bdf140-075e-445e-a62d-633a4b97f3a87
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY5b4da3f8-a5ce-4699-92e1-37fb95e0af2d7
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY932422a8-b72c-4dab-b942-2ab092ed6b017
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYa6bdf140-075e-445e-a62d-633a4b97f3a87
866094busPIRone HCl 5 MG Oral TabletPSN824c80e6-d508-405f-8a4f-2f10df5a9dc86
866094buspirone hydrochloride 5 MG Oral TabletSCD824c80e6-d508-405f-8a4f-2f10df5a9dc86
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY824c80e6-d508-405f-8a4f-2f10df5a9dc86
866083busPIRone HCl 10 MG Oral TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866018busPIRone HCl 15 MG Oral TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866090busPIRone HCl 30 MG Oral TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866094busPIRone HCl 5 MG Oral TabletPSN30c93022-4126-db8c-e063-6394a90a75792
866094busPIRone HCl 5 MG Oral TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866094busPIRone HCl 5 MG Oral TabletPSNfbd7f3fa-11f8-a319-e053-6294a90acae42
866083buspirone hydrochloride 10 MG Oral TabletSCD97f2d082-0931-4e4f-a5be-7792e399e42b2
866018buspirone hydrochloride 15 MG Oral TabletSCD97f2d082-0931-4e4f-a5be-7792e399e42b2
866090buspirone hydrochloride 30 MG Oral TabletSCD97f2d082-0931-4e4f-a5be-7792e399e42b2
866094buspirone hydrochloride 5 MG Oral TabletSCD97f2d082-0931-4e4f-a5be-7792e399e42b2
866094buspirone hydrochloride 5 MG Oral TabletSCD30c93022-4126-db8c-e063-6394a90a75792
866094buspirone hydrochloride 5 MG Oral TabletSCDfbd7f3fa-11f8-a319-e053-6294a90acae42
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY97f2d082-0931-4e4f-a5be-7792e399e42b2
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY97f2d082-0931-4e4f-a5be-7792e399e42b2
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY97f2d082-0931-4e4f-a5be-7792e399e42b2
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYfbd7f3fa-11f8-a319-e053-6294a90acae42
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY97f2d082-0931-4e4f-a5be-7792e399e42b2
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY30c93022-4126-db8c-e063-6394a90a75792
866094busPIRone HCl 5 MG Oral TabletPSN510120d3-c922-a071-e063-6294a90af6a71
866094busPIRone HCl 5 MG Oral TabletPSN37780596-3b6f-8d00-e063-6294a90ad4ad1
866094busPIRone HCl 5 MG Oral TabletPSN1886b672-4b88-4b49-ae6a-d2ba2f452e441
866094buspirone hydrochloride 5 MG Oral TabletSCD510120d3-c922-a071-e063-6294a90af6a71
866094buspirone hydrochloride 5 MG Oral TabletSCD37780596-3b6f-8d00-e063-6294a90ad4ad1
866094buspirone hydrochloride 5 MG Oral TabletSCD1886b672-4b88-4b49-ae6a-d2ba2f452e441
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY510120d3-c922-a071-e063-6294a90af6a71
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY37780596-3b6f-8d00-e063-6294a90ad4ad1
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY1886b672-4b88-4b49-ae6a-d2ba2f452e441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-244-0129300024401100 TABLET in 1 BOTTLE, PLASTIC (29300-244-01) 100 tablet2019-11-200000-00-00NoNoCurrent
29300-244-0529300024405500 TABLET in 1 BOTTLE, PLASTIC (29300-244-05) 500 tablet2019-11-200000-00-00NoNoCurrent