NDC 71209-085

Labetalol Hydrochloride

Labetalol Hydrochloride

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

Product ID71209-085_01a71982-2863-4c51-ae2d-348f7fa09601
NDC71209-085
Product TypeHuman Prescription Drug
Proprietary NameLabetalol Hydrochloride
Generic NameLabetalol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-03-05
Marketing CategoryANDA / ANDA
Application NumberANDA211325
Labeler NameCadila Pharmaceuticals Limited
Substance NameLABETALOL HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71209-085-03

60 TABLET, FILM COATED in 1 BOTTLE (71209-085-03)
Marketing Start Date2018-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71209-085-11 [71209008511]

Labetalol Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA211325
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-30

NDC 71209-085-03 [71209008503]

Labetalol Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA211325
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-30

Drug Details

Active Ingredients

IngredientStrength
LABETALOL HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:5fba93fc-4580-48c2-a1ec-5d446680adcf
Manufacturer
UNII

Pharmacological Class

  • Adrenergic beta-Antagonists [MoA]
  • beta-Adrenergic Blocker [EPC]

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

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
10135-711Labetalol HydrochlorideLabetalol
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

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