Ritonavir
- Product NDC
- 65162-061
- 11-digit product format
- 651620061
- Labeler code
- 65162
- Product ID
- 65162-061_6afba378-b2d9-4ae4-b5b3-cc8811f551d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ritonavir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA208890
- Marketing category
- ANDA
- Marketing start
- 2018-09-21
- Substance
- RITONAVIR
- Active strength
- 100 mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ritonavir
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RITONAVIR | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O3J8G9O825 |
| Rxcui | 900575 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-061-06 | Ritonavir | 60 in 1 BOTTLE | TABLET | 60 | | 24 |
| 65162-061-32 | Ritonavir | 360 in 1 BOTTLE | TABLET | 360 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-061 | RITONAVIR TABLET [AMNEAL PHARMACEUTICALS LLC] | 24 | Current NDC, Legacy NDC, 2 package rows | 20241031_a32cb2e3-d4e5-4bbf-9d88-20b2b249e779.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-061-06 | 65162006106 | 60 TABLET in 1 BOTTLE (65162-061-06) | 60 tablet | 2018-09-21 | 0000-00-00 | No | No | Current |
| 65162-061-32 | 65162006132 | 360 TABLET in 1 BOTTLE (65162-061-32) | 360 tablet | 2018-09-21 | 0000-00-00 | No | No | Current |