FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
72162-1676
11-digit product format
721621676
Labeler code
72162
Product ID
72162-1676_59d59899-30b5-4364-8d7e-2ce7c3c27db2
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
200 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
LABETALOL200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR5H8897N95
Rxcui896762

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
72162-1676-1Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100106
72162-1676-5Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED500106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1676-1EA - Each72162-1676cd50e7cd-521c-4ed4-8854-f54681d253d912023-12-05
72162-1676-5EA - Each72162-16767c398498-5728-4e26-bee9-fc972561731e12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1676LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]105Current NDC, 2 package rows20241020_3909ac9e-6818-4c5d-ad0e-52865a574b45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896762labetalol HCl 200 MG Oral TabletPSN3909ac9e-6818-4c5d-ad0e-52865a574b45106
896762labetalol hydrochloride 200 MG Oral TabletSCD3909ac9e-6818-4c5d-ad0e-52865a574b45106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1676-172162167601100 TABLET, FILM COATED in 1 BOTTLE (72162-1676-1) 2019-11-22NoNoHistorical
72162-1676-572162167605500 TABLET, FILM COATED in 1 BOTTLE (72162-1676-5) 2019-11-22NoNoHistorical