FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
68001-383
11-digit product format
680010383
Labeler code
68001
Product ID
68001-383_ffac2849-40b6-4e5b-e053-6394a90ae38b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BluePoint Laboratories Inc.
Application
ANDA207743
Marketing category
ANDA
Marketing start
2019-02-18
Substance
LABETALOL HYDROCHLORIDE
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LABETALOL HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1GEV3BAW9J

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
68001-383-00Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003
68001-383-03Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-383-00EA - Each68001-38377db3a95-9ded-42e5-ab90-53d4c4ba6e4612019-04-11
68001-383-03EA - Each68001-383adcc257a-95bc-4dd8-b5e2-6fc403cd9e7b12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-383LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES INC.]3Current NDC, Legacy NDC, 2 package rows20230706_63ede355-42ec-4c52-a941-51e5f6b35ed6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN3004aa59-288c-4971-b77b-78789715ef5a6
896762labetalol HCl 200 MG Oral TabletPSN3004aa59-288c-4971-b77b-78789715ef5a6
896766labetalol HCl 300 MG Oral TabletPSN3004aa59-288c-4971-b77b-78789715ef5a6
896758labetalol hydrochloride 100 MG Oral TabletSCD3004aa59-288c-4971-b77b-78789715ef5a6
896762labetalol hydrochloride 200 MG Oral TabletSCD3004aa59-288c-4971-b77b-78789715ef5a6
896766labetalol hydrochloride 300 MG Oral TabletSCD3004aa59-288c-4971-b77b-78789715ef5a6
896758labetalol HCl 100 MG Oral TabletPSN63ede355-42ec-4c52-a941-51e5f6b35ed63
896762labetalol HCl 200 MG Oral TabletPSN63ede355-42ec-4c52-a941-51e5f6b35ed63
896766labetalol HCl 300 MG Oral TabletPSN63ede355-42ec-4c52-a941-51e5f6b35ed63
896758labetalol hydrochloride 100 MG Oral TabletSCD63ede355-42ec-4c52-a941-51e5f6b35ed63
896762labetalol hydrochloride 200 MG Oral TabletSCD63ede355-42ec-4c52-a941-51e5f6b35ed63
896766labetalol hydrochloride 300 MG Oral TabletSCD63ede355-42ec-4c52-a941-51e5f6b35ed63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-383-0068001038300100 TABLET, FILM COATED in 1 BOTTLE (68001-383-00) 2019-02-180000-00-00NoNoCurrent
68001-383-0368001038303500 TABLET, FILM COATED in 1 BOTTLE (68001-383-03) 2019-02-180000-00-00NoNoCurrent