FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
68382-799
11-digit product format
683820799
Labeler code
68382
Product ID
68382-799_49639538-dfdd-4312-9664-701e8bdbe191
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA207743
Marketing category
ANDA
Marketing start
2017-12-05
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
68382-799-01Labetalol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
68382-799-05Labetalol Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5005
68382-799-06Labetalol Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
68382-799-16Labetalol Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-799-01EA - Each68382-799650e8ea6-a826-4c91-8bfc-e681e5a0897512018-04-19
68382-799-05EA - Each68382-7991023a710-6c10-418d-9f19-735d19b3d30f12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-799LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 4 package rows20221014_5942a5a8-c3c1-4ecb-921e-9bc92393bdf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN5942a5a8-c3c1-4ecb-921e-9bc92393bdf85
896762labetalol HCl 200 MG Oral TabletPSN5942a5a8-c3c1-4ecb-921e-9bc92393bdf85
896766labetalol HCl 300 MG Oral TabletPSN5942a5a8-c3c1-4ecb-921e-9bc92393bdf85
896758labetalol hydrochloride 100 MG Oral TabletSCD5942a5a8-c3c1-4ecb-921e-9bc92393bdf85
896762labetalol hydrochloride 200 MG Oral TabletSCD5942a5a8-c3c1-4ecb-921e-9bc92393bdf85
896766labetalol hydrochloride 300 MG Oral TabletSCD5942a5a8-c3c1-4ecb-921e-9bc92393bdf85
896762labetalol HCl 200 MG Oral TabletPSN9c3bb751-c425-43ff-b530-2460b568b6893
896762labetalol hydrochloride 200 MG Oral TabletSCD9c3bb751-c425-43ff-b530-2460b568b6893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-799-0168382079901100 TABLET, FILM COATED in 1 BOTTLE (68382-799-01) 2017-12-050000-00-00NoNoCurrent
68382-799-0568382079905500 TABLET, FILM COATED in 1 BOTTLE (68382-799-05) 2017-12-050000-00-00NoNoCurrent
68382-799-066838207990630 TABLET, FILM COATED in 1 BOTTLE (68382-799-06) 2017-12-050000-00-00NoNoCurrent
68382-799-166838207991690 TABLET, FILM COATED in 1 BOTTLE (68382-799-16) 2017-12-050000-00-00NoNoCurrent