NDC 65483-391

Trandate

Labetalol Hydrochloride

Trandate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Prometheus Laboratories Inc.. The primary component is Labetalol Hydrochloride.

Product ID65483-391_8d2825c1-c676-4a48-bb9f-e0e2b7cc9ee1
NDC65483-391
Product TypeHuman Prescription Drug
Proprietary NameTrandate
Generic NameLabetalol Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1984-05-31
Marketing CategoryNDA / NDA
Application NumberNDA018716
Labeler NamePrometheus Laboratories Inc.
Substance NameLABETALOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 65483-391-10

100 TABLET in 1 BOTTLE (65483-391-10)
Marketing Start Date1984-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65483-391-10 [65483039110]

Trandate TABLET
Marketing CategoryNDA
Application NumberNDA018716
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1984-05-31
Inactivation Date2019-10-29

NDC 65483-391-11 [65483039111]

Trandate TABLET
Marketing CategoryNDA
Application NumberNDA018716
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-05-31
Marketing End Date2010-03-19

NDC 65483-391-50 [65483039150]

Trandate TABLET
Marketing CategoryNDA
Application NumberNDA018716
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-05-31
Marketing End Date2010-03-19

Drug Details

Active Ingredients

IngredientStrength
LABETALOL HYDROCHLORIDE100 mg/1

Pharmacological Class

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

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

NDCBrand NameGeneric Name
65483-393TrandateTrandate
65483-391TrandateTrandate
65483-392TrandateTrandate
0615-8130Labetalol HCLLabetalol Hydrochloride
0615-8131Labetalol HCLLabetalol Hydrochloride
0143-9366Labetalol HCl in DextroseLabetalol Hydrochloride
0143-9363Labetalol HCl in Sodium ChlorideLABETALOL HYDROCHLORIDE
0143-9364Labetalol HCl in Sodium ChlorideLABETALOL HYDROCHLORIDE
0143-9365Labetalol HCl in Sodium ChlorideLABETALOL HYDROCHLORIDE
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
14803-502Labetalol HydrochlorideLabetalol Hydrochloride

Trademark Results [Trandate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRANDATE
TRANDATE
73126182 1090154 Live/Registered
ALLEN & HANBURYS LIMITED
1977-05-11
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