FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
29300-246
11-digit product format
293000246
Labeler code
29300
Product ID
29300-246_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
15 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 HYDROCHLORIDE15 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
29300-246-01Buspirone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1007
29300-246-05Buspirone Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5007
29300-246-16Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET607
29300-246-18Buspirone Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1807

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-246-01EA - Each29300-246ccdee5b6-e928-40c0-880d-0fac4b6803e912020-02-13
29300-246-05EA - Each29300-246adacae12-b88a-48fc-881a-4549fb4d88ce12020-02-13
29300-246-16EA - Each29300-246adc1cba2-9e77-436e-8bde-0a0483b6672412020-02-13
29300-246-18EA - Each29300-2466e43ab55-b261-44ae-b7c2-0586ce285bde12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-246BUSPIRONE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7Current NDC, Legacy NDC, 4 package rows20231223_a6bdf140-075e-445e-a62d-633a4b97f3a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN5fa0720f-e236-4b8b-a0c0-6f48037c76b3103
866018buspirone hydrochloride 15 MG Oral TabletSCD5fa0720f-e236-4b8b-a0c0-6f48037c76b3103
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY5fa0720f-e236-4b8b-a0c0-6f48037c76b3103
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
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 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 TabletSYa6bdf140-075e-445e-a62d-633a4b97f3a87
866018busPIRone HCl 15 MG Oral TabletPSNbce96786-4d9a-460e-8d92-9908ea2af07a6
866018buspirone hydrochloride 15 MG Oral TabletSCDbce96786-4d9a-460e-8d92-9908ea2af07a6
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYbce96786-4d9a-460e-8d92-9908ea2af07a6
866018busPIRone HCl 15 MG Oral TabletPSNda584ae1-4513-6474-e053-2a95a90aac9d5
866018busPIRone HCl 15 MG Oral TabletPSN18ddef0b-1451-4bea-94fb-b6ec27f4744b5
866018buspirone hydrochloride 15 MG Oral TabletSCDda584ae1-4513-6474-e053-2a95a90aac9d5
866018buspirone hydrochloride 15 MG Oral TabletSCD18ddef0b-1451-4bea-94fb-b6ec27f4744b5
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYda584ae1-4513-6474-e053-2a95a90aac9d5
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY18ddef0b-1451-4bea-94fb-b6ec27f4744b5
866018busPIRone HCl 15 MG Oral TabletPSN187c315b-9c2c-485f-aa63-e399e0796e783
866018buspirone hydrochloride 15 MG Oral TabletSCD187c315b-9c2c-485f-aa63-e399e0796e783
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY187c315b-9c2c-485f-aa63-e399e0796e783
866083busPIRone HCl 10 MG Oral TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866018busPIRone HCl 15 MG Oral TabletPSNf98d258d-6479-253a-e053-6394a90acbb32
866018busPIRone HCl 15 MG Oral TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866018busPIRone HCl 15 MG Oral TabletPSNf8afd9b8-0885-2f0c-e053-6294a90a9c572
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 TabletSCD97f2d082-0931-4e4f-a5be-7792e399e42b2
866018buspirone hydrochloride 15 MG Oral TabletSCD97f2d082-0931-4e4f-a5be-7792e399e42b2
866018buspirone hydrochloride 15 MG Oral TabletSCDf98d258d-6479-253a-e053-6394a90acbb32
866018buspirone hydrochloride 15 MG Oral TabletSCDf8afd9b8-0885-2f0c-e053-6294a90a9c572
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 TabletSY97f2d082-0931-4e4f-a5be-7792e399e42b2
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYf98d258d-6479-253a-e053-6394a90acbb32
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYf8afd9b8-0885-2f0c-e053-6294a90a9c572
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-246-0129300024601100 TABLET in 1 BOTTLE, PLASTIC (29300-246-01) 100 tablet2019-11-200000-00-00NoNoCurrent
29300-246-0529300024605500 TABLET in 1 BOTTLE, PLASTIC (29300-246-05) 500 tablet2019-11-200000-00-00NoNoCurrent
29300-246-162930002461660 TABLET in 1 BOTTLE, PLASTIC (29300-246-16) 60 tablet2019-11-200000-00-00NoNoCurrent
29300-246-1829300024618180 TABLET in 1 BOTTLE, PLASTIC (29300-246-18) 180 tablet2019-11-200000-00-00NoNoCurrent