Home NDC 49502-475 SYMFI
Product NDC 49502-475
11-digit product format 495020475
Labeler code 49502
Product ID 49502-475_0a09befe-6075-4bef-bd45-0e41082559d8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Viatris Specialty LLC
Application NDA022142
Marketing category NDA
Marketing start 2018-04-25
Substance EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 600; 300; 300 mg/1; mg/1; mg/1
Pharmacologic classes Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022142-001 SYMFI EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022142-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL RLD, RS 2018-03-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL RLD, RS 2018-03-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL RLD, RS 2018-03-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL RLD, RS 2018-03-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base SYMFI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EFAVIRENZ 600 mg/1 LAMIVUDINE 300 mg/1 TENOFOVIR DISOPROXIL FUMARATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JE6H2O27P8 Internal UNII lookup 2T8Q726O95 Internal UNII lookup OTT9J7900I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864661 Internal RxNorm lookup 2043464 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49502-475-77 SYMFI 1 in 1 CARTON TABLET, FILM COATED 1 6 49502-475-77 SYMFI 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 6 49502-475-93 SYMFI 1 in 1 CARTON TABLET, FILM COATED 1 6 49502-475-93 SYMFI 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49502-475 SYMFI (EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC] 6 Current NDC, Legacy NDC, 4 package rows 20250212_81a55dd9-78a8-49c3-88ab-8f5bffafa359.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SYMFI EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE Viatris Specialty LLC 81a55dd9-78a8-49c3-88ab-8f5bffafa359 2019-10-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022142 application number: NDA022142 ndc (product): 49502-475
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 49502-475-77 49502047577 1 in 1 CARTON Historical 49502-475-93 49502047593 1 BOTTLE, PLASTIC in 1 CARTON (49502-475-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2018-04-25 0000-00-00 No No Current