FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
58657-603
11-digit product format
586570603
Labeler code
58657
Product ID
58657-603_46b55541-52d5-7213-e063-6294a90affc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA075215
Marketing category
ANDA
Marketing start
2019-11-22
Substance
LABETALOL
Active strength
200 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77fProduct name220220311
759f1c41-9262-4238-8cee-33988631aaf4Product name520220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21Product name120210527

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-603-01Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10011
58657-603-10Labetalol Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100011
58657-603-50Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-603-01EA - Each58657-60380483815-10ec-42e0-b9ec-cb86ea4fd32312020-01-03
58657-603-50EA - Each58657-6031338fefb-2ab2-4e53-83dd-be4f1af23d5412020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-603LABETALOL HYDROCHLORIDE TABLET, FILM COATED [METHOD PHARMACEUTICALS, LLC]8Current NDC, Legacy NDC, 3 package rows20241126_733d6e32-ac90-4796-bf25-9d5887c897a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896762labetalol HCl 200 MG Oral TabletPSN3909ac9e-6818-4c5d-ad0e-52865a574b45106
896762labetalol HCl 200 MG Oral TabletPSN64cd636d-8b48-4f29-b41d-4a048335793e106
896762labetalol hydrochloride 200 MG Oral TabletSCD3909ac9e-6818-4c5d-ad0e-52865a574b45106
896762labetalol hydrochloride 200 MG Oral TabletSCD64cd636d-8b48-4f29-b41d-4a048335793e106
896762labetalol HCl 200 MG Oral TabletPSN706a877b-c388-43e7-b083-518111b288b0105
896762labetalol hydrochloride 200 MG Oral TabletSCD706a877b-c388-43e7-b083-518111b288b0105
896762labetalol HCl 200 MG Oral TabletPSN6f919513-500e-4a05-935e-b6fc1615368a103
896762labetalol hydrochloride 200 MG Oral TabletSCD6f919513-500e-4a05-935e-b6fc1615368a103
896762labetalol HCl 200 MG Oral TabletPSN0dcd514d-bda8-484b-8cf1-f5656aaab9ce100
896762labetalol HCl 200 MG Oral TabletPSN20c26652-52da-4eef-8486-f91eb30e9ff7100
896762labetalol hydrochloride 200 MG Oral TabletSCD20c26652-52da-4eef-8486-f91eb30e9ff7100
896762labetalol hydrochloride 200 MG Oral TabletSCD0dcd514d-bda8-484b-8cf1-f5656aaab9ce100
896758labetalol HCl 100 MG Oral TabletPSN733d6e32-ac90-4796-bf25-9d5887c897a511
896762labetalol HCl 200 MG Oral TabletPSN733d6e32-ac90-4796-bf25-9d5887c897a511
896766labetalol HCl 300 MG Oral TabletPSN733d6e32-ac90-4796-bf25-9d5887c897a511
896758labetalol hydrochloride 100 MG Oral TabletSCD733d6e32-ac90-4796-bf25-9d5887c897a511
896762labetalol hydrochloride 200 MG Oral TabletSCD733d6e32-ac90-4796-bf25-9d5887c897a511
896766labetalol hydrochloride 300 MG Oral TabletSCD733d6e32-ac90-4796-bf25-9d5887c897a511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-603-0158657060301100 TABLET, FILM COATED in 1 BOTTLE (58657-603-01) 2019-11-220000-00-00NoNoCurrent
58657-603-10586570603101000 TABLET, FILM COATED in 1 BOTTLE (58657-603-10) 2019-11-220000-00-00NoNoCurrent
58657-603-5058657060350500 TABLET, FILM COATED in 1 BOTTLE (58657-603-50) 2019-11-220000-00-00NoNoCurrent