Lopinavir and Ritonavir
- Product NDC
- 42385-934
- 11-digit product format
- 423850934
- Labeler code
- 42385
- Product ID
- 42385-934_3a3c4164-da47-427d-9f12-6d1f73b0729d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lopinavir and Ritonavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA213857
- Marketing category
- ANDA
- Marketing start
- 2022-03-22
- Substance
- LOPINAVIR; RITONAVIR
- Active strength
- 200; 50 mg/1; 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 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], 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
- Lopinavir and Ritonavir
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOPINAVIR | 200 mg/1 |
| RITONAVIR | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2494G1JF75, O3J8G9O825 |
| Rxcui | 597730, 746645 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-934-12 | Lopinavir and Ritonavir | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42385-934 | LOPINAVIR AND RITONAVIR TABLET, FILM COATED [LAURUS LABS LIMITED] | 2 | Current NDC, Legacy NDC, 1 package rows | 20231021_a7072c60-6dbf-4125-95e7-497c05a9e6a6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42385-934-12 | 42385093412 | 120 TABLET, FILM COATED in 1 BOTTLE (42385-934-12) | 2022-03-22 | 0000-00-00 | No | No | Current |