FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
29300-245
11-digit product format
293000245
Labeler code
29300
Product ID
29300-245_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
10 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 HYDROCHLORIDE10 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
29300-245-01Buspirone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1007
29300-245-05Buspirone Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-245-01EA - Each29300-2458865fce1-a97a-4f3b-bc64-bc339b63fd8212020-02-13
29300-245-05EA - Each29300-24585dde65b-0367-4812-817d-2c1d7d8bdd1f12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-245BUSPIRONE 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
866083busPIRone HCl 10 MG Oral TabletPSNa6bdf140-075e-445e-a62d-633a4b97f3a87
866083busPIRone HCl 10 MG Oral TabletPSN6c6db7a9-a728-406a-81af-edd89e1cc26f7
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
866083buspirone hydrochloride 10 MG Oral TabletSCDa6bdf140-075e-445e-a62d-633a4b97f3a87
866083buspirone hydrochloride 10 MG Oral TabletSCD6c6db7a9-a728-406a-81af-edd89e1cc26f7
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 TabletSCDa6bdf140-075e-445e-a62d-633a4b97f3a87
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY6c6db7a9-a728-406a-81af-edd89e1cc26f7
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 TabletSYa6bdf140-075e-445e-a62d-633a4b97f3a87
866083busPIRone HCl 10 MG Oral TabletPSN068ee1a0-a77a-4803-bad9-18117d7fb3586
866083buspirone hydrochloride 10 MG Oral TabletSCD068ee1a0-a77a-4803-bad9-18117d7fb3586
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY068ee1a0-a77a-4803-bad9-18117d7fb3586
866083busPIRone HCl 10 MG Oral TabletPSNb6352207-e708-44a7-8a63-93b96613e1e75
866083busPIRone HCl 10 MG Oral TabletPSNf71e019b-3928-f8eb-e053-6394a90a871e5
866083buspirone hydrochloride 10 MG Oral TabletSCDb6352207-e708-44a7-8a63-93b96613e1e75
866083buspirone hydrochloride 10 MG Oral TabletSCDf71e019b-3928-f8eb-e053-6394a90a871e5
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYb6352207-e708-44a7-8a63-93b96613e1e75
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYf71e019b-3928-f8eb-e053-6394a90a871e5
866083busPIRone HCl 10 MG Oral TabletPSNd0d8d05c-b495-65d8-e053-2a95a90ae19b3
866083buspirone hydrochloride 10 MG Oral TabletSCDd0d8d05c-b495-65d8-e053-2a95a90ae19b3
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYd0d8d05c-b495-65d8-e053-2a95a90ae19b3
866083busPIRone HCl 10 MG Oral TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866083busPIRone HCl 10 MG Oral TabletPSN801803eb-be17-4064-8813-7ccf52316cde2
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 TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866083buspirone hydrochloride 10 MG Oral TabletSCD801803eb-be17-4064-8813-7ccf52316cde2
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
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY801803eb-be17-4064-8813-7ccf52316cde2
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 TabletSY97f2d082-0931-4e4f-a5be-7792e399e42b2
866083busPIRone HCl 10 MG Oral TabletPSN275ea40c-e869-c5cb-e063-6394a90a13491
866083buspirone hydrochloride 10 MG Oral TabletSCD275ea40c-e869-c5cb-e063-6394a90a13491
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY275ea40c-e869-c5cb-e063-6394a90a13491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-245-0129300024501100 TABLET in 1 BOTTLE, PLASTIC (29300-245-01) 100 tablet2019-11-200000-00-00NoNoCurrent
29300-245-0529300024505500 TABLET in 1 BOTTLE, PLASTIC (29300-245-05) 500 tablet2019-11-200000-00-00NoNoCurrent