FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
72162-1675
11-digit product format
721621675
Labeler code
72162
Product ID
72162-1675_a610bcea-da0a-4f3b-929b-e84e970e30b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075215
Marketing category
ANDA
Marketing start
2019-11-22
Substance
LABETALOL
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
LABETALOL100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR5H8897N95
Rxcui896758

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
72162-1675-1Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100104
72162-1675-5Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED500104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1675-1EA - Each72162-1675fab363e4-5e80-42a4-82c1-5951adc468e712024-01-04
72162-1675-5EA - Each72162-1675c4b7af4c-4376-4585-a1ad-1c72ba7732dd12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1675LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, 2 package rows20250525_35e7bce0-d9ff-4f8b-95c5-218da2a2d929.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN35e7bce0-d9ff-4f8b-95c5-218da2a2d929104
896758labetalol hydrochloride 100 MG Oral TabletSCD35e7bce0-d9ff-4f8b-95c5-218da2a2d929104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1675-172162167501100 TABLET, FILM COATED in 1 BOTTLE (72162-1675-1) 2019-11-22NoNoHistorical
72162-1675-572162167505500 TABLET, FILM COATED in 1 BOTTLE (72162-1675-5) 2019-11-22NoNoHistorical