FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
70377-060
11-digit product format
703770060
Labeler code
70377
Product ID
70377-060_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
100 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 HYDROCHLORIDE100 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
70377-060-11Labetalol Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
70377-060-12Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
70377-060-13Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-060-12EA - Each70377-0600c642c61-04a3-4c56-9e53-306b226194d512021-07-15
70377-060-13EA - Each70377-060ee194457-e66e-41e3-a56b-024594e3763812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-060LABETALOL 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 TabletPSNc0c1a162-cd30-4ac9-bc62-407493ed54a5102
896758labetalol hydrochloride 100 MG Oral TabletSCDc0c1a162-cd30-4ac9-bc62-407493ed54a5102
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 TabletSCD35b5fd32-581d-427b-9a13-b7a02846d21d6
896766labetalol hydrochloride 300 MG Oral TabletSCD27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896983labetalol hydrochloride 400 MG Oral TabletSCD27e4ab03-c17b-4268-912c-e45a5e8f8dd86
896758labetalol HCl 100 MG Oral TabletPSNfaf7a1ff-f18a-8ca7-e053-6394a90a1b1f4
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 TabletSCDfaf7a1ff-f18a-8ca7-e053-6394a90a1b1f4
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
896758labetalol HCl 100 MG Oral TabletPSNb4a5f170-a400-4986-8c64-f55d0413f0f63
896758labetalol HCl 100 MG Oral TabletPSNd207396a-068e-4229-88cc-a1a4df7aeff23
896758labetalol hydrochloride 100 MG Oral TabletSCDb4a5f170-a400-4986-8c64-f55d0413f0f63
896758labetalol hydrochloride 100 MG Oral TabletSCDd207396a-068e-4229-88cc-a1a4df7aeff23
896758labetalol HCl 100 MG Oral TabletPSN30280d40-28df-4c88-93bd-357a7c5289062
896758labetalol HCl 100 MG Oral TabletPSN30281c4d-2fd1-167a-e063-6294a90a77c42
896762labetalol HCl 200 MG Oral TabletPSN30280d40-28df-4c88-93bd-357a7c5289062
896758labetalol hydrochloride 100 MG Oral TabletSCD30280d40-28df-4c88-93bd-357a7c5289062
896758labetalol hydrochloride 100 MG Oral TabletSCD30281c4d-2fd1-167a-e063-6294a90a77c42
896762labetalol hydrochloride 200 MG Oral TabletSCD30280d40-28df-4c88-93bd-357a7c5289062
896758labetalol HCl 100 MG Oral TabletPSN54b75509-824b-4291-818d-71dc1b88915f1
896758labetalol hydrochloride 100 MG Oral TabletSCD54b75509-824b-4291-818d-71dc1b88915f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70377-060-117037700601130 TABLET, FILM COATED in 1 BOTTLE (70377-060-11) 2021-05-270000-00-00NoNoCurrent
70377-060-1270377006012100 TABLET, FILM COATED in 1 BOTTLE (70377-060-12) 2021-05-270000-00-00NoNoCurrent
70377-060-1370377006013500 TABLET, FILM COATED in 1 BOTTLE (70377-060-13) 2021-05-270000-00-00NoNoCurrent