NDC 0615-8131

Labetalol HCL

Labetalol Hydrochloride

Labetalol HCL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Labetalol Hydrochloride.

• Product ID: 0615-8131_4a4d945a-d675-483d-ba43-e6adda4ead30
• NDC: 0615-8131
• Product Type: Human Prescription Drug
• Proprietary Name: Labetalol HCL
• Generic Name: Labetalol Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-07-24
• Marketing End Date: 2022-01-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200908
• Labeler Name: NCS HealthCare of KY, Inc dba Vangard Labs
• Substance Name: LABETALOL HYDROCHLORIDE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0615-8131-39

30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8131-39)

• Marketing Start Date: 2018-03-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0615-8131-39 [00615813139]

Labetalol HCL TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA200908
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-07-24
• Marketing End Date: 2022-01-31

Drug Details

Active Ingredients

Ingredient	Strength
LABETALOL HYDROCHLORIDE	200 mg/1

OpenFDA Data

• SPL SET ID: cce89d14-cc6b-4d86-b84b-309f56637e53
• Manufacturer:
  • NCS HealthCare of KY, Inc dba Vangard Labs
• UNII:
  • 1GEV3BAW9J
• RxNorm Concept Unique ID - RxCUI:
  • 896758
  • 896762

Pharmacological Class

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

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

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
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
49884-123	Labetalol HCL	Labetalol HCL
49884-122	Labetalol HCL	Labetalol HCL
49884-124	Labetalol HCL	Labetalol HCL
50090-1161	Labetalol HCL	Labetalol HCL
50090-1291	Labetalol HCL	Labetalol HCL
51079-929	Labetalol HCl	Labetalol HCl
51079-928	Labetalol HCl	Labetalol HCl
52533-034	Labetalol HCl	Labetalol HCl
55154-5485	Labetalol HCl	Labetalol HCl
60687-125	Labetalol HCl	Labetalol HCl
60687-136	Labetalol HCl	Labetalol HCl
60687-114	Labetalol HCl	Labetalol HCl
63739-366	Labetalol HCl	Labetalol HCl
60760-610	Labetalol HCl	Labetalol HCl
71335-1410	Labetalol HCL	Labetalol HCL
63629-2212	Labetalol HCL	Labetalol HCL
63629-2216	Labetalol HCL	Labetalol HCL
63629-2211	Labetalol HCL	Labetalol HCL
63629-2213	Labetalol HCL	Labetalol HCL
63629-2215	Labetalol HCL	Labetalol HCL
0143-9366	Labetalol HCl in Dextrose	Labetalol Hydrochloride
0143-9363	Labetalol HCl in Sodium Chloride	LABETALOL HYDROCHLORIDE
0143-9364	Labetalol HCl in Sodium Chloride	LABETALOL HYDROCHLORIDE
0143-9365	Labetalol HCl in Sodium Chloride	LABETALOL HYDROCHLORIDE
0143-9320	Labetalol Hydrochloride	Labetalol Hydrochloride
0143-9622	Labetalol Hydrochloride	Labetalol Hydrochloride
0143-9623	Labetalol Hydrochloride	Labetalol Hydrochloride
0409-2267	Labetalol Hydrochloride	Labetalol Hydrochloride
0409-2339	Labetalol Hydrochloride	Labetalol Hydrochloride
0591-0605	Labetalol hydrochloride	Labetalol hydrochloride
0591-0606	Labetalol hydrochloride	Labetalol hydrochloride
0591-0607	Labetalol hydrochloride	Labetalol hydrochloride
0615-4539	Labetalol Hydrochloride	Labetalol Hydrochloride
0615-7686	Labetalol Hydrochloride	Labetalol Hydrochloride
0615-7687	Labetalol Hydrochloride	Labetalol Hydrochloride
0615-7688	Labetalol Hydrochloride	Labetalol Hydrochloride
0641-6252	Labetalol Hydrochloride	Labetalol Hydrochloride
0904-5928	Labetalol hydrochloride	Labetalol hydrochloride