NDC 71930-037

Labetalol Hydrochloride

Labetalol Hydrochloride

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

• Product ID: 71930-037_5fdcf3db-a10a-4e6b-a476-31d04cee1464
• NDC: 71930-037
• Product Type: Human Prescription Drug
• Proprietary Name: Labetalol Hydrochloride
• Generic Name: Labetalol Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207863
• Labeler Name: Eywa Pharma 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: 2023-12-31

Packaging

NDC 71930-037-12

100 TABLET, FILM COATED in 1 BOTTLE (71930-037-12)

• Marketing Start Date: 2019-05-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71930-037-12 [71930003712]

Labetalol Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA207863
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-24

NDC 71930-037-52 [71930003752]

Labetalol Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA207863
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-24

Drug Details

Active Ingredients

Ingredient	Strength
LABETALOL HYDROCHLORIDE	300 mg/1

OpenFDA Data

• SPL SET ID: 891c42c0-6071-5d85-e053-2995a90a4294
• Manufacturer:
  • Eywa Pharma Inc
• UNII:
  • 1GEV3BAW9J

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
0904-5929	Labetalol hydrochloride	Labetalol hydrochloride
0904-5930	Labetalol hydrochloride	Labetalol hydrochloride
0904-7109	Labetalol Hydrochloride	Labetalol Hydrochloride
0904-7110	Labetalol Hydrochloride	Labetalol Hydrochloride
0904-7111	Labetalol Hydrochloride	Labetalol Hydrochloride
10135-711	Labetalol Hydrochloride	Labetalol
68001-381	Labetalol Hydrochloride	Labetalol Hydrochloride
68001-383	Labetalol Hydrochloride	Labetalol Hydrochloride
68001-382	Labetalol Hydrochloride	Labetalol Hydrochloride
68071-3180	Labetalol Hydrochloride	Labetalol Hydrochloride
68083-111	Labetalol Hydrochloride	Labetalol Hydrochloride
68258-6047	Labetalol Hydrochloride	Labetalol Hydrochloride
68382-800	Labetalol Hydrochloride	Labetalol Hydrochloride
68382-798	Labetalol Hydrochloride	Labetalol Hydrochloride
68382-799	Labetalol Hydrochloride	Labetalol Hydrochloride
69292-501	Labetalol Hydrochloride	Labetalol Hydrochloride
69292-503	Labetalol Hydrochloride	Labetalol Hydrochloride
69292-502	Labetalol Hydrochloride	Labetalol Hydrochloride
70518-0027	Labetalol Hydrochloride	Labetalol Hydrochloride
70518-1163	Labetalol Hydrochloride	Labetalol Hydrochloride
70518-1132	Labetalol Hydrochloride	Labetalol Hydrochloride
70518-1887	Labetalol Hydrochloride	Labetalol Hydrochloride
70771-1163	Labetalol Hydrochloride	Labetalol Hydrochloride
70771-1165	Labetalol Hydrochloride	Labetalol Hydrochloride
70771-1164	Labetalol Hydrochloride	Labetalol Hydrochloride
71205-095	Labetalol hydrochloride	Labetalol hydrochloride
71335-0118	Labetalol Hydrochloride	Labetalol Hydrochloride
72266-103	Labetalol Hydrochloride	Labetalol Hydrochloride
72266-102	Labetalol Hydrochloride	Labetalol Hydrochloride
17478-420	Labetalol Hydrochloride	Labetalol Hydrochloride
21695-994	Labetalol hydrochloride	Labetalol hydrochloride
21695-988	Labetalol hydrochloride	Labetalol hydrochloride
21695-592	Labetalol hydrochloride	Labetalol hydrochloride
24979-169	Labetalol Hydrochloride	Labetalol Hydrochloride
24979-170	Labetalol Hydrochloride	Labetalol Hydrochloride
24979-168	Labetalol Hydrochloride	Labetalol Hydrochloride