Viramune
- Product NDC
- 0597-0046
- 11-digit product format
- 005970046
- Labeler code
- 0597
- Product ID
- 0597-0046_625370f8-2aa2-b0fb-b095-35c91cb291da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nevirapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals Inc.
- Application
- NDA020636
- Marketing category
- NDA
- Marketing start
- 2001-08-01
- Marketing end
- 0000-00-00
- Substance
- NEVIRAPINE
- Active strength
- 200 mg/1
- Pharmacologic 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
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a1bab0e5-3c0a-775a-2f29-a19e4e281871 | Product name | 3 | 20190610 |
| d07e0b9e-e041-41dc-942a-a2a6601dc221 | Product name | 1 | 20181029 |
| 0d48f664-b8cd-5c4b-aa8e-0a00f1c0002d | Product name | 8 | 20171204 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0597-0046-46 | EA - Each | 0597-0046 | d5b9b018-bb6f-49ec-870c-8be7d6bb7e48 | 1 | 2012-07-24 |
| 0597-0046-60 | EA - Each | 0597-0046 | f06a0f9a-83ab-4c86-be47-37364d56f6f3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NEVIRAPINE | ACTIVE INGREDIENT | 99DK7FVK1H | VIRAMUNE (NEVIRAPINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| nevirapine | ACTIVE MOIETY | 99DK7FVK1H | VIRAMUNE (NEVIRAPINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | VIRAMUNE (NEVIRAPINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | VIRAMUNE (NEVIRAPINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | VIRAMUNE (NEVIRAPINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | VIRAMUNE (NEVIRAPINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | VIRAMUNE (NEVIRAPINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | VIRAMUNE (NEVIRAPINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199422 | nevirapine 200 MG Oral Tablet | PSN | 46fb9dbc-5345-48a4-a0ec-75039622c76c | 1 |
| 211327 | Viramune 200 MG Oral Tablet | PSN | 46fb9dbc-5345-48a4-a0ec-75039622c76c | 1 |
| 211327 | nevirapine 200 MG Oral Tablet [Viramune] | SBD | 46fb9dbc-5345-48a4-a0ec-75039622c76c | 1 |
| 199422 | nevirapine 200 MG Oral Tablet | SCD | 46fb9dbc-5345-48a4-a0ec-75039622c76c | 1 |
| 211327 | Viramune 200 MG Oral Tablet | SY | 46fb9dbc-5345-48a4-a0ec-75039622c76c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0597-0046-60 | 00597004660 | 60 TABLET in 1 BOTTLE (0597-0046-60) | 60 tablet | 2001-08-01 | 0000-00-00 | No | No | Current |