LABETALOL HYDROCHLORIDE

Product NDC
51662-1228
11-digit product format
516621228
Labeler code
51662
Product ID
51662-1228_9f03d200-e490-fed3-e053-2a95a90a698a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LABETALOL HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA075240
Marketing category
ANDA
Marketing start
2018-09-14
Marketing end
0000-00-00
Substance
LABETALOL HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77fProduct name220220311
759f1c41-9262-4238-8cee-33988631aaf4Product name520220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21Product name120210527
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1228-1LABETALOL HYDROCHLORIDE1 in 1 CARTONINJECTION, SOLUTION16
51662-1228-1LABETALOL HYDROCHLORIDE20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION206
51662-1228-9LABETALOL HYDROCHLORIDE20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1228LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]6Legacy NDC, 3 package rows20200221_75d74177-4e71-cef2-e053-2991aa0a9a97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896771labetalol HCl 5 MG/ML Injectable SolutionPSN75d74177-4e71-cef2-e053-2991aa0a9a976
896771labetalol hydrochloride 5 MG/ML Injectable SolutionSCD75d74177-4e71-cef2-e053-2991aa0a9a976

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1228-1516621228011 VIAL, MULTI-DOSE in 1 CARTON (51662-1228-1) > 20 mL in 1 VIAL, MULTI-DOSE2018-09-140000-00-00NoNoCurrent
51662-1228-95166212280920 mL in 1 VIAL, MULTI-DOSE (51662-1228-9) 20 ml2018-09-140000-00-00NoNoCurrent