FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
60687-461
11-digit product format
606870461
Labeler code
60687
Product ID
60687-461_2a7ffcfa-7d3f-473c-e063-6394a90ad673
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA207743
Marketing category
ANDA
Marketing start
2019-07-16
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
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 HYDROCHLORIDE300 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
60687-461-01Labetalol Hydrochloride100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1006
60687-461-11Labetalol Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-461-01EA - Each60687-46104083eba-3a7d-444b-aba5-b9ae307e616812019-08-06
60687-461-11EA - Each60687-4610f14c14a-f348-460c-956b-3b824d6b63a012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-461LABETALOL HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20250104_3004aa59-288c-4971-b77b-78789715ef5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN3004aa59-288c-4971-b77b-78789715ef5a6
896762labetalol HCl 200 MG Oral TabletPSN3004aa59-288c-4971-b77b-78789715ef5a6
896766labetalol HCl 300 MG Oral TabletPSN3004aa59-288c-4971-b77b-78789715ef5a6
896758labetalol hydrochloride 100 MG Oral TabletSCD3004aa59-288c-4971-b77b-78789715ef5a6
896762labetalol hydrochloride 200 MG Oral TabletSCD3004aa59-288c-4971-b77b-78789715ef5a6
896766labetalol hydrochloride 300 MG Oral TabletSCD3004aa59-288c-4971-b77b-78789715ef5a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-461-0160687046101100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-461-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-461-11) 100 blister pack2019-07-160000-00-00NoNoCurrent
60687-461-11606870461111 in 1 BLISTER PACKHistorical