NDC 55154-5485

Labetalol HCl

Labetalol Hcl

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

• Product ID: 55154-5485_0a4ecd99-de31-41af-bd7e-00ac8f0658e7
• NDC: 55154-5485
• Product Type: Human Prescription Drug
• Proprietary Name: Labetalol HCl
• Generic Name: Labetalol Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-05-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075113
• Labeler Name: Cardinal Health
• Substance Name: LABETALOL HYDROCHLORIDE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55154-5485-0

10 BLISTER PACK in 1 BAG (55154-5485-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2011-05-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55154-5485-0 [55154548500]

Labetalol HCl TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA075113
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-05-06

Drug Details

Active Ingredients

Ingredient	Strength
LABETALOL HYDROCHLORIDE	100 mg/1

OpenFDA Data

• SPL SET ID: 4fa95348-0db7-45f7-bbca-737effa4c6c8
• Manufacturer:
  • Cardinal Health
• UNII:
  • 1GEV3BAW9J
• RxNorm Concept Unique ID - RxCUI:
  • 896758
  • 896762
• UPC Code:
  • 0055154549103
  • 0055154548502

Pharmacological Class

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

NDC Crossover Matching brand name "Labetalol HCl" or generic name "Labetalol Hcl"

NDC	Brand Name	Generic Name
0185-0010	Labetalol HCl	Labetalol HCl
0185-0117	Labetalol HCl	Labetalol HCl
0185-0118	Labetalol HCl	Labetalol HCl
0615-8130	Labetalol HCL	Labetalol Hydrochloride
0615-8131	Labetalol HCL	Labetalol Hydrochloride
49884-122	Labetalol HCL	Labetalol Hydrochloride
49884-123	Labetalol HCL	Labetalol Hydrochloride
49884-124	Labetalol HCL	Labetalol Hydrochloride
50090-1161	Labetalol HCL	Labetalol Hydrochloride
50090-1290	Labetalol HCL	Labetalol Hydrochloride
50090-1291	Labetalol HCL	Labetalol Hydrochloride
51079-928	Labetalol HCl	Labetalol HCl
51079-929	Labetalol HCl	Labetalol HCl
51662-1602	LABETALOL HCl	LABETALOL HCl
52533-034	Labetalol HCl	Labetalol HCl
55154-5485	Labetalol HCl	Labetalol HCl
60687-114	Labetalol HCl	Labetalol HCl
60687-125	Labetalol HCl	Labetalol HCl
60687-136	Labetalol HCl	Labetalol HCl
60760-610	Labetalol HCl	Labetalol HCl
60760-628	Labetalol HCL	Labetalol Hydrochloride
63629-2211	Labetalol HCL	Labetalol Hydrochloride
63629-2212	Labetalol HCL	Labetalol Hydrochloride
63629-2213	Labetalol HCL	Labetalol Hydrochloride
63629-2214	Labetalol HCL	Labetalol Hydrochloride
63629-2215	Labetalol HCL	Labetalol Hydrochloride
63629-2216	Labetalol HCL	Labetalol Hydrochloride
68001-204	Labetalol HCl	Labetalol HCl
68001-205	Labetalol HCl	Labetalol HCl
68001-206	Labetalol HCl	Labetalol HCl
70518-0534	Labetalol HCl	Labetalol HCl
70518-1546	Labetalol HCL	Labetalol HCL
71335-0696	Labetalol HCl	Labetalol HCl
71335-0733	Labetalol HCl	Labetalol HCl
63739-366	Labetalol HCl	Labetalol HCl
71335-1410	Labetalol HCL	Labetalol HCL