Valacyclovir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Valacyclovir Hydrochloride.
| Product ID | 43353-883_5817ec48-bede-499e-ba77-d094e3bdd1ae |
| NDC | 43353-883 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Valacyclovir |
| Generic Name | Valacyclovir Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2010-05-24 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA090682 |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| 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 | 2014-03-07 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA090682 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-03-07 |
| Marketing Category | ANDA |
| Application Number | ANDA090682 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-02-17 |
| Ingredient | Strength |
|---|---|
| VALACYCLOVIR HYDROCHLORIDE | 500 mg/1 |
| SPL SET ID: | 2e8d0add-fa4d-4ec1-80d7-29615c76006c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-7258 | Valacyclovir | Valacyclovir |
| 0093-7259 | 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 |
| 31722-704 | Valacyclovir | Valacyclovir |
| 31722-705 | Valacyclovir | Valacyclovir |
| 43063-771 | Valacyclovir | Valacyclovir |
| 43353-883 | Valacyclovir | Valacyclovir |
| 50090-2575 | Valacyclovir | Valacyclovir |
| 50090-2510 | Valacyclovir | Valacyclovir |
| 51660-904 | VALACYCLOVIR | VALACYCLOVIR |
| 51660-905 | VALACYCLOVIR | VALACYCLOVIR |
| 52343-051 | Valacyclovir | Valacyclovir |
| 52343-052 | Valacyclovir | Valacyclovir |
| 61919-066 | Valacyclovir | Valacyclovir |
| 61919-919 | Valacyclovir | Valacyclovir |
| 63187-950 | Valacyclovir | Valacyclovir |
| 63304-904 | Valacyclovir | Valacyclovir |
| 63304-905 | Valacyclovir | Valacyclovir |
| 65841-630 | Valacyclovir | Valacyclovir |
| 65841-629 | Valacyclovir | Valacyclovir |
| 61919-515 | VALACYCLOVIR | VALACYCLOVIR |
| 63629-7958 | Valacyclovir | Valacyclovir |
| 50436-7050 | Valacyclovir | Valacyclovir |
| 50436-0704 | Valacyclovir | Valacyclovir |
| 70518-2402 | Valacyclovir | Valacyclovir |
| 68071-3332 | Valacyclovir | Valacyclovir |
| 0378-4275 | Valacyclovir Hydrochloride | valacyclovir |
| 0378-4276 | Valacyclovir Hydrochloride | valacyclovir |
| 0781-5208 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride |
| 0781-5209 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride |
| 0904-6565 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride |
| 10544-937 | valacyclovir hydrochloride | valacyclovir hydrochloride |
| 16714-697 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride |
| 0173-0565 | VALTREX | valacyclovir hydrochloride |
| 0173-0933 | VALTREX | valacyclovir hydrochloride |