NDC 10135-711

Labetalol Hydrochloride

Labetalol

Labetalol Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Labetalol.

Product ID10135-711_aeff3fe6-3caa-437a-a4a4-8cd92da704a3
NDC10135-711
Product TypeHuman Prescription Drug
Proprietary NameLabetalol Hydrochloride
Generic NameLabetalol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA075215
Labeler NameMarlex Pharmaceuticals Inc
Substance NameLABETALOL
Active Ingredient Strength100 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 10135-711-01

100 TABLET, FILM COATED in 1 BOTTLE (10135-711-01)
Marketing Start Date2020-10-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Labetalol Hydrochloride" or generic name "Labetalol"

NDCBrand NameGeneric Name
0143-9320Labetalol HydrochlorideLabetalol Hydrochloride
0143-9622Labetalol HydrochlorideLabetalol Hydrochloride
0143-9623Labetalol HydrochlorideLabetalol Hydrochloride
0409-2267Labetalol HydrochlorideLabetalol Hydrochloride
0409-2339Labetalol HydrochlorideLabetalol Hydrochloride
0591-0605Labetalol hydrochlorideLabetalol hydrochloride
0591-0606Labetalol hydrochlorideLabetalol hydrochloride
0591-0607Labetalol hydrochlorideLabetalol hydrochloride
0615-4539Labetalol HydrochlorideLabetalol Hydrochloride
0615-7686Labetalol HydrochlorideLabetalol Hydrochloride
0615-7687Labetalol HydrochlorideLabetalol Hydrochloride
0615-7688Labetalol HydrochlorideLabetalol Hydrochloride
0641-6252Labetalol HydrochlorideLabetalol Hydrochloride
0904-5928Labetalol hydrochlorideLabetalol hydrochloride
0904-5929Labetalol hydrochlorideLabetalol hydrochloride
0904-5930Labetalol hydrochlorideLabetalol hydrochloride
0904-7109Labetalol HydrochlorideLabetalol Hydrochloride
0904-7110Labetalol HydrochlorideLabetalol Hydrochloride
0904-7111Labetalol HydrochlorideLabetalol Hydrochloride
68001-381Labetalol HydrochlorideLabetalol Hydrochloride
68001-383Labetalol HydrochlorideLabetalol Hydrochloride
68001-382Labetalol HydrochlorideLabetalol Hydrochloride
68071-3180Labetalol HydrochlorideLabetalol Hydrochloride
68083-111Labetalol HydrochlorideLabetalol Hydrochloride
68258-6047Labetalol HydrochlorideLabetalol Hydrochloride
68382-800Labetalol HydrochlorideLabetalol Hydrochloride
68382-798Labetalol HydrochlorideLabetalol Hydrochloride
68382-799Labetalol HydrochlorideLabetalol Hydrochloride
69292-501Labetalol HydrochlorideLabetalol Hydrochloride
69292-503Labetalol HydrochlorideLabetalol Hydrochloride
69292-502Labetalol HydrochlorideLabetalol Hydrochloride
70518-0027Labetalol HydrochlorideLabetalol Hydrochloride
70518-1163Labetalol HydrochlorideLabetalol Hydrochloride
70518-1132Labetalol HydrochlorideLabetalol Hydrochloride
70518-1887Labetalol HydrochlorideLabetalol Hydrochloride
70771-1163Labetalol HydrochlorideLabetalol Hydrochloride
70771-1165Labetalol HydrochlorideLabetalol Hydrochloride
70771-1164Labetalol HydrochlorideLabetalol Hydrochloride
71205-095Labetalol hydrochlorideLabetalol hydrochloride
71335-0118Labetalol HydrochlorideLabetalol Hydrochloride
72266-103Labetalol HydrochlorideLabetalol Hydrochloride
72266-102Labetalol HydrochlorideLabetalol Hydrochloride
17478-420Labetalol HydrochlorideLabetalol Hydrochloride
21695-994Labetalol hydrochlorideLabetalol hydrochloride
21695-988Labetalol hydrochlorideLabetalol hydrochloride
21695-592Labetalol hydrochlorideLabetalol hydrochloride
24979-169Labetalol HydrochlorideLabetalol Hydrochloride
24979-170Labetalol HydrochlorideLabetalol Hydrochloride
24979-168Labetalol HydrochlorideLabetalol Hydrochloride
43199-037Labetalol HydrochlorideLabetalol Hydrochloride

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.