SYMFI LO

Product NDC: 49502-425
11-digit product format: 495020425
Labeler code: 49502
Product ID: 49502-425_b3c95eed-7579-40b4-bf99-1530b71a975a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Specialty L.P.
Application: NDA208255
Marketing category: NDA
Marketing start: 2018-03-13
Marketing end: 0000-00-00
Substance: EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength: 400 mg/1; mg/1; mg/1
Pharmacologic classes: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49502-425		D	Discontinued by firm		2026-10-05
excluded package	package	49502-425	49502-425-93	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	49502-425		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49502-425	49502-425-93	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N208255-001	SYMFI LO	EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL		RLD	2018-02-05

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 · 43 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
2026-09-14 22:38:34	2026-08	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL		RLD	2018-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL		RLD	2018-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL		RLD	2018-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL		RLD, RS	2018-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL		RLD, RS	2018-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL		RLD, RS	2018-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL		RLD, RS	2018-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208255-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208255-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208255-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208255-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208255-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208255-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208255-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208255-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208255-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208255-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208255-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208255-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208255-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208255-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208255-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208255-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208255-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208255-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208255-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208255-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208255-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208255-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208255-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208255-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208255-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208255-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208255-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208255-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208255-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208255-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208255-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208255-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208255-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208255-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208255-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33cd1557-9629-1a35-1f2f-499cf7c608bc	Product name	2	20260305
aaa99659-c62c-7281-d402-9590409850c2	Product name	6	20260128
5f93de8c-a439-4aaa-862f-7cf2524cb240	Product name	3	20250812
a02e6d35-8cc4-a80a-fd4d-d3ec16f69b8e	Product name	8	20250626
649b204e-4c3b-7f17-657b-ae3f2995e611	Product name	7	20250220
6286e356-28a5-4b4b-a174-76bf53b211e3	Product name	6	20250121
233e3f87-da6c-4b7d-80cb-963ca3258270	Product name	2	20240419
c0c98dbe-5e23-74e9-f9fc-07af05f77d95	Product name	8	20240319
4ef90d80-1289-4267-a2bb-01c741d1208f	Product name	1	20230829
72dcca4e-6eae-4149-a92b-264c2a07004f	Product name	1	20230808
3832141c-c294-474a-9473-1052c891450e	Product name	2	20230105
1cd1fd33-94db-4c45-bd26-82773ea350a3	Product name	2	20220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690f	Product name	4	20220314
320f244d-8b4e-4893-9f14-104b2a8e0aaf	Product name	2	20201007
7ff71f22-5b66-4a3d-bf64-671893a6409d	Product name	2	20201007
3644e9cf-6f4d-4b63-b875-6a4b5187c47e	Product name	1	20190703
0e579b5c-f0b5-e690-466e-4a5e809e2c68	Product name	3	20190627
6f122144-2ceb-48fa-a906-0d2eb742717e	Product name	1	20190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67	Product name	1	20181211
fbdbfbef-2c33-0298-4fef-f6693e670fe1	Product name	7	20181210
d07e0b9e-e041-41dc-942a-a2a6601dc221	Product name	1	20181029
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7	Product name	1	20180911
03a109f6-6ebe-4ce1-a7d1-c1e0e0cbeb0b	Product name	1	20180221
d1784558-3c5f-4d73-8a7c-051102bb6c92	Product name	1	20160405
7fd46899-3505-4ed4-b856-6b2509a76004	Product name	1	20151123
af19b329-4f44-cd81-491a-fbb7fe7a079f	Product name	2	20151013
c873f14e-2add-4d53-b9b3-bf775efd3702	Product name	1	20150325
0583b5e6-2e6e-c94b-9ff6-81a81ba199de	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49502-425-93	EA - Each	49502-425	c79edcc0-ae32-48bd-a846-5916e595605f	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49502-425	SYMFI LO (EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC]	8	Legacy NDC	20250212_86aad85d-5460-4c38-9761-a225e6bce190.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JE6H2O27P8	EFAVIRENZ	154598-52-4	EFAVIRENZ
2T8Q726O95	LAMIVUDINE	134678-17-4	LAMIVUDINE
OTT9J7900I	TENOFOVIR DISOPROXIL FUMARATE	202138-50-9	TENOFOVIR DISOPROXIL FUMARATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49502-425-93	49502042593	1 BOTTLE, PLASTIC in 1 CARTON (49502-425-93) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2018-03-13	0000-00-00	No	No	Current