CIMDUO
- Product NDC
- 49502-450
- 11-digit product format
- 495020450
- Labeler code
- 49502
- Product ID
- 49502-450_e63f53ae-04f8-4bbc-afa1-c62078f09855
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamivudine and Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Viatris Specialty LLC
- Application
- NDA022141
- Marketing category
- NDA
- Marketing start
- 2018-06-25
- Substance
- LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 300; 300 mg/1; mg/1
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CIMDUO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMIVUDINE | 300 mg/1 |
| TENOFOVIR DISOPROXIL FUMARATE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2T8Q726O95, OTT9J7900I |
| Rxcui | 2003249, 2003255 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49502-450-77 | CIMDUO | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 5 |
| 49502-450-77 | CIMDUO | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 49502-450-93 | CIMDUO | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 49502-450-93 | CIMDUO | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49502-450 | CIMDUO (LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250210_a300f04d-118f-4136-aaf3-ddfd00197f86.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 |
|---|
| 49502-450-77 | 49502045077 | 90 in 1 BOTTLE, PLASTIC | | | | | Historical |
| 49502-450-93 | 49502045093 | 1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2018-06-25 | 0000-00-00 | No | No | Current |