Viramune
- Product NDC
- 53808-0808
- 11-digit product format
- 538080808
- Labeler code
- 53808
- Product ID
- 53808-0808_46b0051f-5908-4d1d-967b-4085a0909b4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nevirapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- NDA020636
- Marketing category
- NDA
- Marketing start
- 2009-07-01
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-0808-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-ce9d-621f-e053-dbdaa90a74ad | These highlights do not include all the information needed to use VIRAMUNE safely and effectively. See full prescribing information for VIRAMUNE. Viramune® (nevirapine) tablets 200 mg Viramune® (nevirapine) oral suspension 50 mg/5 mL Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0808-1 | Viramune | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
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 Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0808 | VIRAMUNE (NEVIRAPINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20100611_46fb9dbc-5345-48a4-a0ec-75039622c76c.zip |
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 | Status |
|---|---|---|---|
| 53808-0808-1 | 53808080801 | 30 in 1 BLISTER PACK | Historical |