NDC 0185-0118

Labetalol HCl

Labetalol Hcl

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

• Product ID: 0185-0118_303007af-9fb1-447a-98a8-5f22b99f0249
• NDC: 0185-0118
• 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: 1998-08-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075113
• Labeler Name: Eon Labs, Inc.
• Substance Name: LABETALOL HYDROCHLORIDE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0185-0118-01

100 TABLET, FILM COATED in 1 BOTTLE (0185-0118-01)

• Marketing Start Date: 1998-08-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0185-0118-01 [00185011801]

Labetalol HCl TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA075113
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-08-04

NDC 0185-0118-10 [00185011810]

Labetalol HCl TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA075113
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1998-08-04

NDC 0185-0118-05 [00185011805]

Labetalol HCl TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA075113
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-08-04

Drug Details

Active Ingredients

Ingredient	Strength
LABETALOL HYDROCHLORIDE	300 mg/1

OpenFDA Data

• SPL SET ID: 1111acdb-1f6a-4b5e-955b-a50efe998914
• Manufacturer:
  • Eon Labs, Inc.
• UNII:
  • 1GEV3BAW9J
• RxNorm Concept Unique ID - RxCUI:
  • 896758
  • 896766
  • 896762

Pharmacological Class

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