FDA.reportPublic FDA data

Labetalol HCL

Product NDC
50090-1290
11-digit product format
500901290
Labeler code
50090
Product ID
50090-1290_0797ccb6-b00c-4ee4-91f3-a55705048b96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200908
Marketing category
ANDA
Marketing start
2012-07-24
Substance
LABETALOL HYDROCHLORIDE
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LABETALOL HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1GEV3BAW9J
Rxcui896758, 896762, 896766

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77fProduct name220220311
759f1c41-9262-4238-8cee-33988631aaf4Product name520220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1290-02023-02-07C16284748780-19d75b9d0-c3a6-f424-e053-dadaa90a57ceLabetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only
50090-1290-12023-02-07C16284748780-19d75b9d0-c3a6-f424-e053-dadaa90a57ceLabetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only
50090-1290-02023-01-30C16284748780-19d75b9d0-c3a6-f424-e053-dadaa90a57ceLabetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only
50090-1290-12023-01-30C16284748780-19d75b9d0-c3a6-f424-e053-dadaa90a57ceLabetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1290-0Labetalol HCL100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10045
50090-1290-1Labetalol HCL90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9045

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1290-0EA - Each50090-12906bbab1f9-9a65-446a-817a-bb405e406a1612018-11-06
50090-1290-1EA - Each50090-12909dac5e8b-9a9e-416b-97cf-8baa7185ba2b12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1290LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]43Current NDC, Legacy NDC, 2 package rows20250406_312dde0d-5147-483e-968f-4e0d46114176.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN312dde0d-5147-483e-968f-4e0d4611417645
896762labetalol HCl 200 MG Oral TabletPSN312dde0d-5147-483e-968f-4e0d4611417645
896766labetalol HCl 300 MG Oral TabletPSN312dde0d-5147-483e-968f-4e0d4611417645
896758labetalol hydrochloride 100 MG Oral TabletSCD312dde0d-5147-483e-968f-4e0d4611417645
896762labetalol hydrochloride 200 MG Oral TabletSCD312dde0d-5147-483e-968f-4e0d4611417645
896766labetalol hydrochloride 300 MG Oral TabletSCD312dde0d-5147-483e-968f-4e0d4611417645

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1290-050090129000100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1290-0) 2014-11-280000-00-00NoNoCurrent
50090-1290-15009012900190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1290-1) 2015-08-060000-00-00NoNoCurrent