Prescription drug · NDA
Cimduo NDC 49502-450
lamivudine and tenofovir disoproxil fumarate · Lamivudine 300 mg/1; Tenofovir disoproxil fumarate 300 mg/1 · Tablet, Film coated · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49502-450-93 | 49502045093 | 1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Jun 25, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cimduo
- Generic name (nonproprietary)
- lamivudine and tenofovir disoproxil fumarate
- Active ingredients
- Lamivudine — 300 mg/1Tenofovir disoproxil fumarate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Viatris Specialty LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022141
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
- Identifiers
- Product ID 49502-450_e63f53ae-04f8-4bbc-afa1-c62078f09855SPL ID e63f53ae-04f8-4bbc-afa1-c62078f09855SPL set ID a300f04d-118f-4136-aaf3-ddfd00197f86RxCUI 2003249, 2003255UNII 2T8Q726O95, OTT9J7900I
- Pharmacologic class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N449502045093followed by a unit qualifier and the quantityPackage 49502-0450-93. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
CIMDUO ® (lamivudine and tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. CIMDUO is a two-drug combination of lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. ( 1 )
Excerpt only. Read the full label for complete information.