FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
58657-602
11-digit product format
586570602
Labeler code
58657
Product ID
58657-602_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
100 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
LABETALOL100 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
58657-602-01Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10011
58657-602-10Labetalol Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100011
58657-602-50Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-602-01EA - Each58657-6023a5d7015-c0f5-4b9a-9c1b-3bd257072b5412020-01-03
58657-602-50EA - Each58657-602c48a438a-ffed-40b8-81e3-144c1a8ad79712020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-602LABETALOL 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
896758labetalol HCl 100 MG Oral TabletPSN1fce27dd-90a6-45cf-9bd7-13147d3cc0d7107
896758labetalol hydrochloride 100 MG Oral TabletSCD1fce27dd-90a6-45cf-9bd7-13147d3cc0d7107
896758labetalol HCl 100 MG Oral TabletPSN143ae21e-c350-4c92-b318-7537f4e46596106
896758labetalol hydrochloride 100 MG Oral TabletSCD143ae21e-c350-4c92-b318-7537f4e46596106
896758labetalol HCl 100 MG Oral TabletPSN35e7bce0-d9ff-4f8b-95c5-218da2a2d929104
896758labetalol hydrochloride 100 MG Oral TabletSCD35e7bce0-d9ff-4f8b-95c5-218da2a2d929104
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
896758labetalol HCl 100 MG Oral TabletPSNe2e50571-d8c1-43e7-b90f-877ba1c35c9b4
896758labetalol hydrochloride 100 MG Oral TabletSCDe2e50571-d8c1-43e7-b90f-877ba1c35c9b4
896758labetalol HCl 100 MG Oral TabletPSNd8b69cc9-bdee-4e24-a3d8-d1887de5a17d1
896758labetalol hydrochloride 100 MG Oral TabletSCDd8b69cc9-bdee-4e24-a3d8-d1887de5a17d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-602-0158657060201100 TABLET, FILM COATED in 1 BOTTLE (58657-602-01) 2019-11-220000-00-00NoNoCurrent
58657-602-10586570602101000 TABLET, FILM COATED in 1 BOTTLE (58657-602-10) 2019-11-220000-00-00NoNoCurrent
58657-602-5058657060250500 TABLET, FILM COATED in 1 BOTTLE (58657-602-50) 2019-11-220000-00-00NoNoCurrent