Labetalol Hydrochloride

Product NDC
71930-037
11-digit product format
719300037
Labeler code
71930
Product ID
71930-037_5fdcf3db-a10a-4e6b-a476-31d04cee1464
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA207863
Marketing category
ANDA
Marketing start
2019-05-24
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-037-12EA - Each71930-03705659054-3763-47cf-9a7c-c77ae3b2806a12019-07-02
71930-037-52EA - Each71930-037e612b9b1-7605-4954-97cc-5179349af68512019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-037LABETALOL HYDROCHLORIDE TABLET, FILM COATED [EYWA PHARMA INC]5Legacy NDC20250523_891c42c0-6071-5d85-e053-2995a90a4294.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896766labetalol HCl 300 MG Oral TabletPSNb25c0287-1709-4859-93b4-4ea18801d19f102
896766labetalol HCl 300 MG Oral TabletPSNecb357ea-ba26-4d8a-b10a-5110f777414b102
896766labetalol hydrochloride 300 MG Oral TabletSCDb25c0287-1709-4859-93b4-4ea18801d19f102
896766labetalol hydrochloride 300 MG Oral TabletSCDecb357ea-ba26-4d8a-b10a-5110f777414b102
896766labetalol HCl 300 MG Oral TabletPSNe2848ca6-ad8c-4e03-a2b9-12b1d02311353
896766labetalol hydrochloride 300 MG Oral TabletSCDe2848ca6-ad8c-4e03-a2b9-12b1d02311353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71930-037-1271930003712100 TABLET, FILM COATED in 1 BOTTLE (71930-037-12) 2019-05-240000-00-00NoNoCurrent
71930-037-5271930003752500 TABLET, FILM COATED in 1 BOTTLE (71930-037-52) 2019-05-240000-00-00NoNoCurrent