Labetalol hydrochloride

Product NDC
21695-592
11-digit product format
216950592
Labeler code
21695
Product ID
21695-592_7cdbf66c-9548-47ac-b79a-10a9934c1a29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075133
Marketing category
ANDA
Marketing start
1998-08-03
Marketing end
0000-00-00
Substance
LABETALOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-592-30Labetalol hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
21695-592-60Labetalol hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-592-30EA - Each21695-5921f8008f6-f84e-40ad-8a1c-5768afcfebef12012-07-24
21695-592-60EA - Each21695-59215e49ae2-60b2-4b88-b7c9-ad3da606aa1712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LABETALOL HYDROCHLORIDEACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-592LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20111220_d555e256-c8ba-414e-8bba-4e1222356d14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSNd555e256-c8ba-414e-8bba-4e1222356d142
896758labetalol hydrochloride 100 MG Oral TabletSCDd555e256-c8ba-414e-8bba-4e1222356d142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-592-302169505923030 in 1 BOTTLE, PLASTICHistorical
21695-592-602169505926060 in 1 BOTTLE, PLASTICHistorical