FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
0904-7452
11-digit product format
009047452
Labeler code
0904
Product ID
0904-7452_25dba2c0-ab5f-48c1-8768-533d26a16b53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA209603
Marketing category
ANDA
Marketing start
2024-10-08
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
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
LABETALOL HYDROCHLORIDE200 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
0904-7452-61Labetalol Hydrochloride100 in 1 CARTONTABLET, FILM COATED1006
0904-7452-61Labetalol Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7452-61EA - Each0904-7452bbd48f29-4e9e-45fc-84ae-28950af0e63a12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7452LABETALOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3Current NDC, 2 package rows20250224_35b5fd32-581d-427b-9a13-b7a02846d21d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN35b5fd32-581d-427b-9a13-b7a02846d21d6
896762labetalol HCl 200 MG Oral TabletPSN35b5fd32-581d-427b-9a13-b7a02846d21d6
896766labetalol HCl 300 MG Oral TabletPSN35b5fd32-581d-427b-9a13-b7a02846d21d6
896758labetalol hydrochloride 100 MG Oral TabletSCD35b5fd32-581d-427b-9a13-b7a02846d21d6
896762labetalol hydrochloride 200 MG Oral TabletSCD35b5fd32-581d-427b-9a13-b7a02846d21d6
896766labetalol hydrochloride 300 MG Oral TabletSCD35b5fd32-581d-427b-9a13-b7a02846d21d6
896758labetalol HCl 100 MG Oral TabletPSNd3ca153c-25b2-4506-91bd-bf9d6a4c01fe4
896762labetalol HCl 200 MG Oral TabletPSNd3ca153c-25b2-4506-91bd-bf9d6a4c01fe4
896766labetalol HCl 300 MG Oral TabletPSNd3ca153c-25b2-4506-91bd-bf9d6a4c01fe4
896758labetalol hydrochloride 100 MG Oral TabletSCDd3ca153c-25b2-4506-91bd-bf9d6a4c01fe4
896762labetalol hydrochloride 200 MG Oral TabletSCDd3ca153c-25b2-4506-91bd-bf9d6a4c01fe4
896766labetalol hydrochloride 300 MG Oral TabletSCDd3ca153c-25b2-4506-91bd-bf9d6a4c01fe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7452-6100904745261100 BLISTER PACK in 1 CARTON (0904-7452-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2024-10-08NoNoHistorical