Labetalol HCL

Product NDC
60760-628
11-digit product format
607600628
Labeler code
60760
Product ID
60760-628_c8ad3090-0526-6aa5-e053-2a95a90a65cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA200908
Marketing category
ANDA
Marketing start
2021-07-27
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
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-628-90EA - Each60760-62812476ef7-7a8d-4336-8786-4c1d8da0f79212021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-628LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]1Legacy NDC20210805_c8ad238a-0c94-28ea-e053-2995a90a778d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-628-906076006289090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-628-90) 2021-07-270000-00-00NoNoCurrent