Labetalol Hydrochloride

Product NDC
71930-036
11-digit product format
719300036
Labeler code
71930
Product ID
71930-036_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
200 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
71930-036-12EA - Each71930-0362ac5fff7-0ce0-4431-97f6-c5fb569d98d712019-07-02
71930-036-52EA - Each71930-03640950413-643f-497d-a347-03f44d083d3812019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-036LABETALOL 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
896762labetalol HCl 200 MG Oral TabletPSNd073b03d-057d-44eb-a3a7-8f439b965c8a102
896762labetalol hydrochloride 200 MG Oral TabletSCDd073b03d-057d-44eb-a3a7-8f439b965c8a102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71930-036-1271930003612100 TABLET, FILM COATED in 1 BOTTLE (71930-036-12) 2019-05-240000-00-00NoNoCurrent
71930-036-5271930003652500 TABLET, FILM COATED in 1 BOTTLE (71930-036-52) 2019-05-240000-00-00NoNoCurrent