NDC 0597-0123
Viramune
Nevirapine
Viramune is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Nevirapine.
| Product ID | 0597-0123_946f43a1-62b5-dda9-1666-b63deef016ac |
| NDC | 0597-0123 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Viramune |
| Generic Name | Nevirapine |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-04-11 |
| Marketing Category | NDA / NDA |
| Application Number | NDA201152 |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Substance Name | NEVIRAPINE |
| Active Ingredient Strength | 400 mg/1 |
| Pharm Classes | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0597-0123-30
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0123-30)
| Marketing Start Date | 2011-04-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0597-0123-30 [00597012330]
Viramune TABLET, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA201152 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-04-11 |
NDC 0597-0123-03 [00597012303]
Viramune TABLET, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA201152 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-04-11 |
| Marketing End Date | 2017-04-11 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| NEVIRAPINE | 400 mg/1 |
OpenFDA Data
| SPL SET ID: | 82598cb3-a0eb-4ff2-8b8d-d8da96c25388 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- Non-Nucleoside Analog [EXT]
- Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
- Cytochrome P450 3A Inducers [MoA]
- Cytochrome P450 2B6 Inducers [MoA]
NDC Crossover Matching brand name "Viramune" or generic name "Nevirapine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0597-0046 | Viramune | nevirapine |
| 0597-0047 | Viramune | nevirapine |
| 0597-0123 | Viramune | nevirapine |
| 53808-0808 | Viramune | nevirapine |
| 0378-4050 | Nevirapine | nevirapine |
| 0378-4890 | Nevirapine | nevirapine |
| 0378-6950 | Nevirapine | nevirapine |
| 0781-5893 | Nevirapine | Nevirapine |
| 31722-505 | Nevirapine | Nevirapine |
| 33342-004 | Nevirapine | Nevirapine |
| 33342-238 | NEVIRAPINE | NEVIRAPINE |
| 42571-131 | NEVIRAPINE | NEVIRAPINE |
| 51991-331 | Nevirapine | NEVIRAPINE |
| 53104-0166 | nevirapine | nevirapine |
| 53808-0680 | Nevirapine | nevirapine |
| 53808-1069 | nevirapine | nevirapine |
| 61442-470 | Nevirapine | Nevirapine |
| 64380-709 | Nevirapine | Nevirapine |
| 65162-209 | Nevirapine | Nevirapine |
| 47781-317 | Nevirapine Extended Release | nevirapine |
Trademark Results [Viramune]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIRAMUNE 74423308 1905263 Live/Registered |
BOEHRINGER INGELHEIM PHARMACUETICALS, INC. 1993-08-12 |
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