NDC codes

FDA NDC Directory
Product NDC (as listed)49502-450Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49502-0450Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
49502-450-9349502045093495020450931 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 LLCNDC labeler code 49502
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

N449502045093 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 49502-450

What is NDC 49502-450?
49502-450 is the product NDC for Cimduo, Lamivudine 300 mg/1; Tenofovir disoproxil fumarate 300 mg/1 tablet, film coated, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cimduo (Lamivudine and Tenofovir Disoproxil Fumarate).
What is the active ingredient?
Lamivudine, Tenofovir disoproxil fumarate.
Who is the labeler?
Viatris Specialty LLC, NDC labeler code 49502. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cimduo?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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