FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
42543-741
11-digit product format
425430741
Labeler code
42543
Product ID
42543-741_2357cfc5-edfb-40d5-8b55-2c7f11704091
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Inc.
Application
ANDA202330
Marketing category
ANDA
Marketing start
2021-04-01
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866090, 866094, 866111

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
42543-741-06Buspirone Hydrochloride100 in 1 BOTTLETABLET1004
42543-741-07Buspirone Hydrochloride500 in 1 BOTTLETABLET5004
42543-741-08Buspirone Hydrochloride1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-741-07EA - Each42543-741485c6e7b-cc95-48f7-a692-003e75b880da12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-741BUSPIRONE HYDROCHLORIDE TABLET [STRIDES PHARMA INC.]3Current NDC, Legacy NDC, 3 package rows20240622_cb0091ad-97f6-431b-b2b9-e03171eed274.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866018busPIRone HCl 15 MG Oral TabletPSNbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866090busPIRone HCl 30 MG Oral TabletPSNbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866094busPIRone HCl 5 MG Oral TabletPSNbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866111busPIRone HCl 7.5 MG Oral TabletPSNbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866083buspirone hydrochloride 10 MG Oral TabletSCDbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866018buspirone hydrochloride 15 MG Oral TabletSCDbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866090buspirone hydrochloride 30 MG Oral TabletSCDbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866094buspirone hydrochloride 5 MG Oral TabletSCDbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866111buspirone hydrochloride 7.5 MG Oral TabletSCDbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866083busPIRone HCl 10 MG Oral TabletPSNcb0091ad-97f6-431b-b2b9-e03171eed2744
866018busPIRone HCl 15 MG Oral TabletPSNcb0091ad-97f6-431b-b2b9-e03171eed2744
866090busPIRone HCl 30 MG Oral TabletPSNcb0091ad-97f6-431b-b2b9-e03171eed2744
866094busPIRone HCl 5 MG Oral TabletPSNcb0091ad-97f6-431b-b2b9-e03171eed2744
866111busPIRone HCl 7.5 MG Oral TabletPSNcb0091ad-97f6-431b-b2b9-e03171eed2744
866083buspirone hydrochloride 10 MG Oral TabletSCDcb0091ad-97f6-431b-b2b9-e03171eed2744
866018buspirone hydrochloride 15 MG Oral TabletSCDcb0091ad-97f6-431b-b2b9-e03171eed2744
866090buspirone hydrochloride 30 MG Oral TabletSCDcb0091ad-97f6-431b-b2b9-e03171eed2744
866094buspirone hydrochloride 5 MG Oral TabletSCDcb0091ad-97f6-431b-b2b9-e03171eed2744
866111buspirone hydrochloride 7.5 MG Oral TabletSCDcb0091ad-97f6-431b-b2b9-e03171eed2744
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYcb0091ad-97f6-431b-b2b9-e03171eed2744
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYcb0091ad-97f6-431b-b2b9-e03171eed2744
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYcb0091ad-97f6-431b-b2b9-e03171eed2744
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYcb0091ad-97f6-431b-b2b9-e03171eed2744
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYcb0091ad-97f6-431b-b2b9-e03171eed2744

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42543-741-0642543074106100 TABLET in 1 BOTTLE (42543-741-06) 100 tablet2021-04-010000-00-00NoNoCurrent
42543-741-0742543074107500 TABLET in 1 BOTTLE (42543-741-07) 500 tablet2021-04-010000-00-00NoNoCurrent
42543-741-08425430741081000 TABLET in 1 BOTTLE (42543-741-08) 1000 tablet2021-04-010000-00-00NoNoCurrent