Labetalol Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cadila Pharmaceuticals Limited. The primary component is Labetalol Hydrochloride.
| Product ID | 71209-085_01a71982-2863-4c51-ae2d-348f7fa09601 |
| NDC | 71209-085 |
| 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 | 2018-03-05 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA211325 |
| Labeler Name | Cadila Pharmaceuticals Limited |
| 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 |
| Marketing Start Date | 2018-06-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA211325 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-06-30 |
| Marketing Category | ANDA |
| Application Number | ANDA211325 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-06-30 |
| Ingredient | Strength |
|---|---|
| LABETALOL HYDROCHLORIDE | 300 mg/1 |
| SPL SET ID: | 5fba93fc-4580-48c2-a1ec-5d446680adcf |
| Manufacturer | |
| UNII |
| 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 |