Buspirone Hydrochloride

Product NDC
70518-3686
11-digit product format
705183686
Labeler code
70518
Product ID
70518-3686_5022fca5-a2c9-9651-e063-6294a90ad7e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2023-03-20
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
Rxcui866094

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
70518-3686-0Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET307
70518-3686-1Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET307
70518-3686-2Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET907
70518-3686-3Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET307
70518-3686-4Buspirone Hydrochloride50 in 1 BOXTABLET507
70518-3686-5Buspirone Hydrochloride1 in 1 POUCHTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3686BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]3Current NDC, 6 package rows20240328_5b4da3f8-a5ce-4699-92e1-37fb95e0af2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSN5b4da3f8-a5ce-4699-92e1-37fb95e0af2d7
866094buspirone hydrochloride 5 MG Oral TabletSCD5b4da3f8-a5ce-4699-92e1-37fb95e0af2d7
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY5b4da3f8-a5ce-4699-92e1-37fb95e0af2d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3686-07051836860030 TABLET in 1 BLISTER PACK (70518-3686-0) 30 tablet2023-03-20NoNoHistorical
70518-3686-17051836860130 TABLET in 1 BOTTLE, PLASTIC (70518-3686-1) 30 tablet2025-06-19NoNoHistorical
70518-3686-27051836860290 TABLET in 1 BOTTLE, PLASTIC (70518-3686-2) 90 tablet2025-08-22NoNoHistorical
70518-3686-37051836860330 TABLET in 1 BLISTER PACK (70518-3686-3) 30 tablet2026-03-06NoNoHistorical
70518-3686-47051836860450 POUCH in 1 BOX (70518-3686-4) / 1 TABLET in 1 POUCH (70518-3686-5) 50 pouch2026-04-23NoNoHistorical
70518-3686-5705183686051 in 1 POUCHHistorical