cimduo

Generic: lamivudine and tenofovir disoproxil fumarate

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cimduo
Generic Name lamivudine and tenofovir disoproxil fumarate
Labeler viatris specialty llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lamivudine 300 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 49502-450
Product ID 49502-450_e63f53ae-04f8-4bbc-afa1-c62078f09855
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022141
Listing Expiration 2026-12-31
Marketing Start 2018-06-25

Pharmacologic Class

Established (EPC)
hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49502450
Hyphenated Format 49502-450

Supplemental Identifiers

RxCUI
2003249 2003255
UNII
2T8Q726O95 OTT9J7900I
NUI
N0000175656 N0000175462 N0000009947

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cimduo (source: ndc)
Generic Name lamivudine and tenofovir disoproxil fumarate (source: ndc)
Application Number NDA022141 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

49502-450-93 1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (2)

lamivudine (300 mg/1) tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

CIMDUO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e63f53ae-04f8-4bbc-afa1-c62078f09855", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "unii": ["2T8Q726O95", "OTT9J7900I"], "rxcui": ["2003249", "2003255"], "spl_set_id": ["a300f04d-118f-4136-aaf3-ddfd00197f86"], "pharm_class_epc": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93)  / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "49502-450-93", "marketing_start_date": "20180625"}], "brand_name": "CIMDUO", "product_id": "49502-450_e63f53ae-04f8-4bbc-afa1-c62078f09855", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "49502-450", "generic_name": "Lamivudine and Tenofovir Disoproxil Fumarate", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CIMDUO", "active_ingredients": [{"name": "LAMIVUDINE", "strength": "300 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "NDA022141", "marketing_category": "NDA", "marketing_start_date": "20180625", "listing_expiration_date": "20261231"}