Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC: 0378-1930
11-digit product format: 003781930
Labeler code: 0378
Product ID: 0378-1930_d21888d6-d5a8-49fe-9e07-e854cf78b712
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA206436
Marketing category: ANDA
Marketing start: 2021-03-30
Marketing end: 0000-00-00
Substance: EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength: 200 mg/1; mg/1
Pharmacologic classes: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],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: 2022-12-31
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	0378-1930		D	Discontinued by firm		2026-10-05
excluded package	package	0378-1930	0378-1930-93	D	Discontinued by firm		2026-10-05

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
A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL			2018-04-09

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2018-04-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2018-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2018-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2018-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL		2018-04-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206436-001	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	2018-04-09	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206436-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206436-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206436-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206436-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206436-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206436-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206436-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206436-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206436-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206436-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206436-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206436-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206436-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206436-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206436-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206436-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206436-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206436-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206436-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206436-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206436-001	AB	1	`87673890dc5c…`
2019-12-14 00:12 UTC	2019-12	A206436-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206436-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206436-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206436-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206436-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206436-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206436-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206436-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206436-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206436-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206436-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206436-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206436-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206436-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206436-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206436-001	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
5f93de8c-a439-4aaa-862f-7cf2524cb240	Product name	3	20250812
6286e356-28a5-4b4b-a174-76bf53b211e3	Product name	6	20250121
233e3f87-da6c-4b7d-80cb-963ca3258270	Product name	2	20240419
dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4	Product name	3	20240320
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
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
6f122144-2ceb-48fa-a906-0d2eb742717e	Product name	1	20190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67	Product name	1	20181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7	Product name	1	20180911
d1784558-3c5f-4d73-8a7c-051102bb6c92	Product name	1	20160405
7fd46899-3505-4ed4-b856-6b2509a76004	Product name	1	20151123
0583b5e6-2e6e-c94b-9ff6-81a81ba199de	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-1930-93	Emtricitabine and Tenofovir Disoproxil Fumarate	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1930-93	EA - Each	0378-1930	99c39051-c716-41c0-888f-caf417982141	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-1930	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5	Legacy NDC, 1 package rows	20250101_d21888d6-d5a8-49fe-9e07-e854cf78b712.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G70B4ETF4S	EMTRICITABINE	143491-57-0	EMTRICITABINE
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
0378-1930-93	00378193093	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1930-93)	2021-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Emtricitabine and Tenofovir Disoproxil Fumarate	Mylan Pharmaceuticals Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	5