Valacyclovir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Valacyclovir Hydrochloride.
| Product ID | 68382-225_1dbc09c9-e29c-4c0c-8897-4fe89eeffef1 |
| NDC | 68382-225 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Valacyclovir |
| Generic Name | Valacyclovir |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-04-05 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA079137 |
| Labeler Name | Zydus Pharmaceuticals (USA) Inc. |
| Substance Name | VALACYCLOVIR HYDROCHLORIDE |
| Active Ingredient Strength | 500 mg/1 |
| Pharm Classes | DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-04-05 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA079137 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-04-05 |
| Marketing Category | ANDA |
| Application Number | ANDA079137 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-04-05 |
| Marketing Category | ANDA |
| Application Number | ANDA079137 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-04-05 |
| Marketing Category | ANDA |
| Application Number | ANDA079137 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-04-05 |
| Marketing Category | ANDA |
| Application Number | ANDA079137 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-04-05 |
| Marketing End Date | 2019-12-05 |
| Ingredient | Strength |
|---|---|
| VALACYCLOVIR HYDROCHLORIDE | 500 mg/1 |
| SPL SET ID: | 272c1aab-426f-4d7d-a3ea-235fdcb6003a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-7258 | Valacyclovir | Valacyclovir |
| 0093-7259 | Valacyclovir | Valacyclovir |
| 31722-704 | Valacyclovir | Valacyclovir |
| 31722-705 | Valacyclovir | Valacyclovir |
| 43063-771 | Valacyclovir | Valacyclovir |
| 43353-883 | Valacyclovir | Valacyclovir Hydrochloride |
| 50090-2510 | Valacyclovir | Valacyclovir |
| 50090-2575 | Valacyclovir | Valacyclovir |
| 50436-0704 | Valacyclovir | Valacyclovir |
| 50436-7050 | Valacyclovir | Valacyclovir |
| 51407-107 | Valacyclovir | Valacyclovir |
| 51407-108 | Valacyclovir | Valacyclovir |
| 51660-904 | VALACYCLOVIR | VALACYCLOVIR HYDROCHLORIDE |
| 51660-905 | VALACYCLOVIR | VALACYCLOVIR HYDROCHLORIDE |
| 52343-051 | Valacyclovir | valacyclovir hydrochloride |
| 52343-052 | Valacyclovir | valacyclovir hydrochloride |
| 55700-913 | Valacyclovir | Valacyclovir |
| 60760-469 | Valacyclovir | Valacyclovir |
| 61919-066 | Valacyclovir | Valacyclovir |
| 61919-515 | VALACYCLOVIR | VALACYCLOVIR |
| 61919-919 | Valacyclovir | Valacyclovir |
| 68071-3135 | Valacyclovir | Valacyclovir |
| 68071-3276 | Valacyclovir | Valacyclovir |
| 68071-3372 | Valacyclovir | Valacyclovir |
| 68071-4805 | Valacyclovir | Valacyclovir |
| 68382-226 | Valacyclovir | Valacyclovir |
| 68382-225 | Valacyclovir | Valacyclovir |
| 70518-0323 | Valacyclovir | Valacyclovir |
| 70934-106 | Valacyclovir | Valacyclovir |
| 71335-0630 | Valacyclovir | Valacyclovir |
| 63187-950 | Valacyclovir | Valacyclovir |
| 63304-904 | Valacyclovir | Valacyclovir |
| 63304-905 | Valacyclovir | Valacyclovir |
| 65841-630 | Valacyclovir | Valacyclovir |
| 65841-629 | Valacyclovir | Valacyclovir |
| 63629-7958 | Valacyclovir | Valacyclovir |
| 70518-2402 | Valacyclovir | Valacyclovir |
| 68071-3332 | Valacyclovir | Valacyclovir |
| 0378-4275 | Valacyclovir Hydrochloride | valacyclovir |
| 0378-4276 | Valacyclovir Hydrochloride | valacyclovir |