FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
70377-062
11-digit product format
703770062
Labeler code
70377
Product ID
70377-062_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
2021-05-27
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
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 HYDROCHLORIDE300 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
70377-062-11Labetalol Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
70377-062-12Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
70377-062-13Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-062-12EA - Each70377-0626d53a421-9ca5-4658-b990-18b023ff02fb12021-07-15
70377-062-13EA - Each70377-06238828578-0366-4875-9746-5c6c41eb46d812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-062LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BIOCON PHARMA INC.]2Current NDC, Legacy 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
896758labetalol HCl 100 MG Oral TabletPSN35b5fd32-581d-427b-9a13-b7a02846d21d6
896762labetalol HCl 200 MG Oral TabletPSN27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896762labetalol HCl 200 MG Oral TabletPSN35b5fd32-581d-427b-9a13-b7a02846d21d6
896766labetalol HCl 300 MG Oral TabletPSN27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896766labetalol HCl 300 MG Oral TabletPSN35b5fd32-581d-427b-9a13-b7a02846d21d6
896983labetalol HCl 400 MG Oral TabletPSN27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896758labetalol hydrochloride 100 MG Oral TabletSCD27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896758labetalol hydrochloride 100 MG Oral TabletSCD35b5fd32-581d-427b-9a13-b7a02846d21d6
896762labetalol hydrochloride 200 MG Oral TabletSCD27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896762labetalol hydrochloride 200 MG Oral TabletSCD35b5fd32-581d-427b-9a13-b7a02846d21d6
896766labetalol hydrochloride 300 MG Oral TabletSCD27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896766labetalol hydrochloride 300 MG Oral TabletSCD35b5fd32-581d-427b-9a13-b7a02846d21d6
896983labetalol hydrochloride 400 MG Oral TabletSCD27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896758labetalol HCl 100 MG Oral TabletPSNd5ce687f-4a37-d3e6-e053-2995a90aa9744
896762labetalol HCl 200 MG Oral TabletPSNd5ce687f-4a37-d3e6-e053-2995a90aa9744
896766labetalol HCl 300 MG Oral TabletPSNd5ce687f-4a37-d3e6-e053-2995a90aa9744
896758labetalol hydrochloride 100 MG Oral TabletSCDd5ce687f-4a37-d3e6-e053-2995a90aa9744
896762labetalol hydrochloride 200 MG Oral TabletSCDd5ce687f-4a37-d3e6-e053-2995a90aa9744
896766labetalol hydrochloride 300 MG Oral TabletSCDd5ce687f-4a37-d3e6-e053-2995a90aa9744
896766labetalol HCl 300 MG Oral TabletPSNd4364caf-46c6-4144-9ba5-2c561e4f3a953
896766labetalol hydrochloride 300 MG Oral TabletSCDd4364caf-46c6-4144-9ba5-2c561e4f3a953
896766labetalol HCl 300 MG Oral TabletPSNdafa7411-2857-4f5a-a587-4367cfbe2bfa2
896766labetalol HCl 300 MG Oral TabletPSN1e1b7355-4802-d277-e063-6394a90aef442
896766labetalol hydrochloride 300 MG Oral TabletSCDdafa7411-2857-4f5a-a587-4367cfbe2bfa2
896766labetalol hydrochloride 300 MG Oral TabletSCD1e1b7355-4802-d277-e063-6394a90aef442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70377-062-117037700621130 TABLET, FILM COATED in 1 BOTTLE (70377-062-11) 2021-05-270000-00-00NoNoCurrent
70377-062-1270377006212100 TABLET, FILM COATED in 1 BOTTLE (70377-062-12) 2021-05-270000-00-00NoNoCurrent
70377-062-1370377006213500 TABLET, FILM COATED in 1 BOTTLE (70377-062-13) 2021-05-270000-00-00NoNoCurrent