Truvada

Product NDC: 50090-0870
11-digit product format: 500900870
Labeler code: 50090
Product ID: 50090-0870_cb9a6580-9a40-4659-a9ac-0e918e645524
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: emtricitabine and tenofovir disoproxil fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA021752
Marketing category: NDA
Marketing start: 2004-08-02
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-0870		I	Inactivated by FDA	2026-08-11
excluded package	package	50090-0870	50090-0870-0	I	Inactivated by FDA	2026-08-11
excluded package	package	50090-0870	50090-0870-2	I	Inactivated by FDA	2026-08-11
excluded package	package	50090-0870	50090-0870-3	I	Inactivated by FDA	2026-08-11

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0870-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0870-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0870-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0870-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0870-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0870-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0870-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0870-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0870-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0870-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0870-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0870-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0870-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0870-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0870-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0870-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0870-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0870-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0870-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0870-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0870-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0870-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0870-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0870-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-0870-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-0870-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-0870-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-0870-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-0870-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-0870-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0870-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0870-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0870-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0870-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0870-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0870-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-0870-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-0870-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-0870-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-0870-0	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-0870-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-0870-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-0870-0	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-0870-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-0870-2	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021752-001	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02
N021752-002	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10
N021752-003	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10
N021752-004	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021752-001	AB
N021752-002	AB
N021752-003	AB
N021752-004	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 5 · 164 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	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 146 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021752-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021752-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021752-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-004	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 390 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	8592397	2024-01-13	U-248	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	8592397	2024-01-13	U-541	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	8592397	2024-01-13	U-1170	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	8592397	2024-01-13	U-248	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	8592397	2024-01-13	U-541	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	8592397	2024-01-13	U-1170	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	8592397	2024-01-13	U-248	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	8592397	2024-01-13	U-541	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	8592397	2024-01-13	U-1170	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	8592397	2024-01-13	U-248	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	8592397	2024-01-13	U-541	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	8592397	2024-01-13	U-1170	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021752-001	8592397	2024-01-13	U-248	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-001	8592397	2024-01-13	U-541	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-001	8592397	2024-01-13	U-1170	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	8592397	2024-01-13	U-248	Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	8592397	2024-01-13	U-541	Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	8592397	2024-01-13	U-1170	Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021752-001	8592397	2024-01-13	U-248	Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021752-001	8592397	2024-01-13	U-541	Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021752-001	8592397	2024-01-13	U-1170	Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`301d65b070ca…`

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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0870-0	2023-01-30	C162847	48780-1	f386c64a-0a24-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
50090-0870-2	2023-01-30	C162847	48780-1	f386c64a-0a24-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
50090-0870-3	2023-01-30	C162847	48780-1	f386c64a-0a24-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-0870-0	Truvada	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	12
50090-0870-2	Truvada	5 in 1 BOTTLE	TABLET, FILM COATED	5	12
50090-0870-3	Truvada	3 in 1 BOTTLE	TABLET, FILM COATED	3	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0870-0	EA - Each	50090-0870	f1db03f5-6ef4-4d89-a571-68b353aabc99	1	2018-10-11
50090-0870-2	EA - Each	50090-0870	69cc1779-1267-4d68-b2b0-6e7a975b7681	1	2018-10-11
50090-0870-3	EA - Each	50090-0870	3b4272cb-f628-41d7-b205-5d5551805975	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0870	TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	12	Legacy NDC, 3 package rows	20210616_00b4b5b5-7220-410c-8db2-dd940498cfc2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Truvada	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Gilead Sciences, Inc	54e82b13-a037-49ed-b4b3-030b37c0ecdd	2025-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021752 application number: NDA021752
Truvada	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	NuCare Pharmaceuticals,Inc.	46e06df0-654d-43cc-e054-00144ff8d46c	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021752 application number: NDA021752

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	00b4b5b5-7220-410c-8db2-dd940498cfc2	12
639888	Truvada 200 MG / 300 MG Oral Tablet	PSN	00b4b5b5-7220-410c-8db2-dd940498cfc2	12
639888	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada]	SBD	00b4b5b5-7220-410c-8db2-dd940498cfc2	12
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	00b4b5b5-7220-410c-8db2-dd940498cfc2	12
476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	00b4b5b5-7220-410c-8db2-dd940498cfc2	12
639888	Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet	SY	00b4b5b5-7220-410c-8db2-dd940498cfc2	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0870-0	50090087000	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0870-0)	2014-11-28	0000-00-00	No	No	Current
50090-0870-2	50090087002	5 TABLET, FILM COATED in 1 BOTTLE (50090-0870-2)	2014-11-28	0000-00-00	No	No	Current
50090-0870-3	50090087003	3 TABLET, FILM COATED in 1 BOTTLE (50090-0870-3)	2014-11-28	0000-00-00	No	No	Current