FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
70377-063
11-digit product format
703770063
Labeler code
70377
Product ID
70377-063_f285cda1-e518-405e-9362-292ae2e14954
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA209603
Marketing category
ANDA
Marketing start
2024-12-02
Substance
LABETALOL HYDROCHLORIDE
Active strength
400 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 HYDROCHLORIDE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1GEV3BAW9J
Rxcui896758, 896762, 896766, 896983

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
70377-063-11Labetalol Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
70377-063-12Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
70377-063-13Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-063-11EA - Each70377-063e504b212-55d7-44c8-8589-50a5f8667e1c12025-10-14
70377-063-12EA - Each70377-063121e8a3b-b45b-4815-af36-0a4396cac87812025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-063LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BIOCON PHARMA INC.]2Current NDC, 3 package rows20241203_27e4ab03-c17b-4268-912c-e45a5e8f8dd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896762labetalol HCl 200 MG Oral TabletPSN27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896766labetalol HCl 300 MG Oral TabletPSN27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896983labetalol HCl 400 MG Oral TabletPSN27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896758labetalol hydrochloride 100 MG Oral TabletSCD27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896762labetalol hydrochloride 200 MG Oral TabletSCD27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896766labetalol hydrochloride 300 MG Oral TabletSCD27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896983labetalol hydrochloride 400 MG Oral TabletSCD27e4ab03-c17b-4268-912c-e45a5e8f8dd86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70377-063-117037700631130 TABLET, FILM COATED in 1 BOTTLE (70377-063-11) 2025-08-07NoNoCurrent
70377-063-1270377006312100 TABLET, FILM COATED in 1 BOTTLE (70377-063-12) 2024-12-02NoNoCurrent
70377-063-1370377006313500 TABLET, FILM COATED in 1 BOTTLE (70377-063-13) 2024-12-02NoNoCurrent