FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
58657-604
11-digit product format
586570604
Labeler code
58657
Product ID
58657-604_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
300 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

Additional Listing Data#

Finished product
Yes
Brand name base
Labetalol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LABETALOL300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR5H8897N95
Rxcui896758, 896762, 896766

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
58657-604-01Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10011
58657-604-10Labetalol Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100011
58657-604-50Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-604-01EA - Each58657-6048b2c1976-4298-4a64-956b-0bdaa37f314512020-01-03
58657-604-50EA - Each58657-6045a7f3aaf-e40b-4343-ad51-2044646a3ad912020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-604LABETALOL 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
896766labetalol HCl 300 MG Oral TabletPSN5a39bb96-4a60-49e8-859c-16bda0fe18e4107
896766labetalol HCl 300 MG Oral TabletPSNf7f7fade-98a6-4741-bfb9-f1eb54ad4565107
896766labetalol hydrochloride 300 MG Oral TabletSCD5a39bb96-4a60-49e8-859c-16bda0fe18e4107
896766labetalol hydrochloride 300 MG Oral TabletSCDf7f7fade-98a6-4741-bfb9-f1eb54ad4565107
896766labetalol HCl 300 MG Oral TabletPSN94abdd54-a8e2-4858-8183-6c5d04dbceb5105
896766labetalol hydrochloride 300 MG Oral TabletSCD94abdd54-a8e2-4858-8183-6c5d04dbceb5105
896766labetalol HCl 300 MG Oral TabletPSN0db22a64-1863-4188-850b-273ea746e327103
896766labetalol hydrochloride 300 MG Oral TabletSCD0db22a64-1863-4188-850b-273ea746e327103
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
58657-604-0158657060401100 TABLET, FILM COATED in 1 BOTTLE (58657-604-01) 2019-11-220000-00-00NoNoCurrent
58657-604-10586570604101000 TABLET, FILM COATED in 1 BOTTLE (58657-604-10) 2019-11-220000-00-00NoNoCurrent
58657-604-5058657060450500 TABLET, FILM COATED in 1 BOTTLE (58657-604-50) 2019-11-220000-00-00NoNoCurrent