FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
71247-126
11-digit product format
712470126
Labeler code
71247
Product ID
71247-126_09304c97-8d53-4561-b157-765544fd362c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Innogenix, Inc.
Application
ANDA075215
Marketing category
ANDA
Marketing start
2021-02-08
Substance
LABETALOL HYDROCHLORIDE
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
LABETALOL HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1GEV3BAW9J
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
71247-126-01Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1007
71247-126-05Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71247-126-01EA - Each71247-1267aa681f6-a8ed-43a6-8bd7-65ae68aa2cb312021-03-02
71247-126-05EA - Each71247-126da1b8d55-1974-42c0-baca-6b83e3c1317712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71247-126LABETALOL HYDROCHLORIDE TABLET, FILM COATED [INNOGENIX, INC.]6Current NDC, Legacy NDC, 2 package rows20240402_82fc2d64-0572-4a9b-94fc-f6eb8d930c54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN82fc2d64-0572-4a9b-94fc-f6eb8d930c547
896762labetalol HCl 200 MG Oral TabletPSN82fc2d64-0572-4a9b-94fc-f6eb8d930c547
896766labetalol HCl 300 MG Oral TabletPSN82fc2d64-0572-4a9b-94fc-f6eb8d930c547
896758labetalol hydrochloride 100 MG Oral TabletSCD82fc2d64-0572-4a9b-94fc-f6eb8d930c547
896762labetalol hydrochloride 200 MG Oral TabletSCD82fc2d64-0572-4a9b-94fc-f6eb8d930c547
896766labetalol hydrochloride 300 MG Oral TabletSCD82fc2d64-0572-4a9b-94fc-f6eb8d930c547

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71247-126-0171247012601100 TABLET, FILM COATED in 1 BOTTLE (71247-126-01) 2021-02-080000-00-00NoNoCurrent
71247-126-0571247012605500 TABLET, FILM COATED in 1 BOTTLE (71247-126-05) 2021-02-080000-00-00NoNoCurrent