Lopinavir and ritonavir
- Product NDC
- 31722-603
- 11-digit product format
- 317220603
- Labeler code
- 31722
- Product ID
- 31722-603_c3de2763-2221-d566-e053-2995a90ab15f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lopinavir and ritonavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA091677
- Marketing category
- ANDA
- Marketing start
- 2021-06-07
- Substance
- LOPINAVIR; RITONAVIR
- Active strength
- 100; 25 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 | 100 mg/1 |
| RITONAVIR | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O3J8G9O825, 2494G1JF75 |
| Rxcui | 597730, 746645 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-603-12 | Lopinavir and ritonavir | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 1 |
| 31722-603-60 | Lopinavir and ritonavir | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-603 | LOPINAVIR AND RITONAVIR (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210607_4e5005b8-f00c-4671-be09-bb927190760f.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 |
|---|
| 31722-603-12 | 31722060312 | 120 TABLET, FILM COATED in 1 BOTTLE (31722-603-12) | 2021-06-07 | 0000-00-00 | No | No | Current |
| 31722-603-60 | 31722060360 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-603-60) | 2021-06-07 | 0000-00-00 | No | No | Current |