Nevirapine
- Product NDC
- 53808-0680
- 11-digit product format
- 538080680
- Labeler code
- 53808
- Product ID
- 53808-0680_e15b05c5-0ba5-4f29-985a-63d8ec3f97af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nevirapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA202523
- Marketing category
- ANDA
- Marketing start
- 2013-01-01
- 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
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 53808-0680-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7baf-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use nevirapine tablets safely and effectively. See full prescribing information for nevirapine tablets. Nevirapine Tablets USP, 200 mg Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0680-1 | Nevirapine | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NEVIRAPINE | ACTIVE INGREDIENT | 99DK7FVK1H | NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| NEVIRAPINE | ACTIVE MOIETY | 99DK7FVK1H | NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0680 | NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20140415_e6267bd6-dd60-48d7-969c-c3ebaf113eb7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199422 | nevirapine 200 MG Oral Tablet | PSN | e6267bd6-dd60-48d7-969c-c3ebaf113eb7 | 1 |
| 199422 | nevirapine 200 MG Oral Tablet | SCD | e6267bd6-dd60-48d7-969c-c3ebaf113eb7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0680-1 | 53808068001 | 30 in 1 BLISTER PACK | Historical |