Viread

Product NDC: 50090-0754
Requested package NDC: 50090-0754-0
11-digit product format: 500900754
Labeler code: 50090
Product ID: 50090-0754_ffa93c8c-b423-4326-baea-d60e37882173
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TENOFOVIR DISOPROXIL FUMARATE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA021356
Marketing category: NDA
Marketing start: 2001-10-26
Marketing end: 0000-00-00
Substance: TENOFOVIR DISOPROXIL FUMARATE
Active strength: 300 mg/1
Pharmacologic classes: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-0754	50090-0754-0	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N021356-001	VIREAD	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	RLD, RS	2001-10-26
N021356-002	VIREAD	TENOFOVIR DISOPROXIL FUMARATE	150MG	TABLET / ORAL	AB	RLD	2012-01-18
N021356-003	VIREAD	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	RLD	2012-01-18
N021356-004	VIREAD	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	RLD	2012-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021356-001	AB
N021356-002	AB
N021356-003	AB
N021356-004	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	N021356-001	VIREAD	300MG	TABLET / ORAL	AB	RLD, RS	2001-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021356-002	VIREAD	150MG	TABLET / ORAL	AB	RLD	2012-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021356-003	VIREAD	200MG	TABLET / ORAL	AB	RLD	2012-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021356-004	VIREAD	250MG	TABLET / ORAL	AB	RLD	2012-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021356-001	VIREAD	300MG	TABLET / ORAL	AB	RLD, RS	2001-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021356-002	VIREAD	150MG	TABLET / ORAL	AB	RLD	2012-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021356-003	VIREAD	200MG	TABLET / ORAL	AB	RLD	2012-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021356-004	VIREAD	250MG	TABLET / ORAL	AB	RLD	2012-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021356-001	VIREAD	300MG	TABLET / ORAL	AB	RLD, RS	2001-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021356-002	VIREAD	150MG	TABLET / ORAL	AB	RLD	2012-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021356-003	VIREAD	200MG	TABLET / ORAL	AB	RLD	2012-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021356-004	VIREAD	250MG	TABLET / ORAL	AB	RLD	2012-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021356-001	VIREAD	300MG	TABLET / ORAL	AB	RLD, RS	2001-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021356-002	VIREAD	150MG	TABLET / ORAL	AB	RLD	2012-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021356-003	VIREAD	200MG	TABLET / ORAL	AB	RLD	2012-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021356-004	VIREAD	250MG	TABLET / ORAL	AB	RLD	2012-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021356-001	VIREAD	300MG	TABLET / ORAL	AB	RLD, RS	2001-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021356-002	VIREAD	150MG	TABLET / ORAL	AB	RLD	2012-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021356-003	VIREAD	200MG	TABLET / ORAL	AB	RLD	2012-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021356-004	VIREAD	250MG	TABLET / ORAL	AB	RLD	2012-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021356-001	VIREAD	300MG	TABLET / ORAL	AB	RLD, RS	2001-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021356-002	VIREAD	150MG	TABLET / ORAL	AB	RLD	2012-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021356-003	VIREAD	200MG	TABLET / ORAL	AB	RLD	2012-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021356-004	VIREAD	250MG	TABLET / ORAL	AB	RLD	2012-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021356-001	VIREAD	300MG	TABLET / ORAL	AB	RLD, RS	2001-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021356-002	VIREAD	150MG	TABLET / ORAL	AB	RLD	2012-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021356-003	VIREAD	200MG	TABLET / ORAL	AB	RLD	2012-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021356-004	VIREAD	250MG	TABLET / ORAL	AB	RLD	2012-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021356-001	VIREAD	300MG	TABLET / ORAL	AB	RLD, RS	2001-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021356-002	VIREAD	150MG	TABLET / ORAL	AB	RLD	2012-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021356-003	VIREAD	200MG	TABLET / ORAL	AB	RLD	2012-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021356-004	VIREAD	250MG	TABLET / ORAL	AB	RLD	2012-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021356-001	VIREAD	300MG	TABLET / ORAL	AB	RLD, RS	2001-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021356-002	VIREAD	150MG	TABLET / ORAL	AB	RLD	2012-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021356-003	VIREAD	200MG	TABLET / ORAL	AB	RLD	2012-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021356-004	VIREAD	250MG	TABLET / ORAL	AB	RLD	2012-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021356-001	VIREAD	300MG	TABLET / ORAL	AB	RLD, RS	2001-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021356-002	VIREAD	150MG	TABLET / ORAL	AB	RLD	2012-01-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021356-003	VIREAD	200MG	TABLET / ORAL	AB	RLD	2012-01-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021356-004	VIREAD	250MG	TABLET / ORAL	AB	RLD	2012-01-18	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	N021356-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021356-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021356-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021356-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021356-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021356-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021356-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021356-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021356-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021356-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021356-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021356-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021356-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021356-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021356-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021356-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021356-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021356-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021356-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021356-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021356-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021356-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021356-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021356-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021356-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021356-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021356-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021356-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021356-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021356-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021356-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021356-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021356-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021356-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021356-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021356-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021356-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021356-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021356-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021356-004	AB	1	`d06236e962d9…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021356-001	PED	2022-06-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021356-002	PED	2022-06-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021356-003	PED	2022-06-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021356-004	PED	2022-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021356-001	PED	2022-06-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021356-002	PED	2022-06-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021356-003	PED	2022-06-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021356-004	PED	2022-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021356-001	PED	2022-06-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021356-002	PED	2022-06-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021356-003	PED	2022-06-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021356-004	PED	2022-06-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021356-001	NPP	2021-12-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021356-001	PED	2022-06-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021356-002	NPP	2021-12-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021356-002	PED	2022-06-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021356-003	NPP	2021-12-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021356-003	PED	2022-06-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021356-004	NPP	2021-12-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021356-004	PED	2022-06-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021356-001	PED	2022-06-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021356-002	PED	2022-06-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021356-003	PED	2022-06-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021356-004	PED	2022-06-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021356-001	NPP	2021-12-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021356-001	PED	2022-06-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021356-002	NPP	2021-12-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021356-002	PED	2022-06-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021356-003	NPP	2021-12-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021356-003	PED	2022-06-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021356-004	NPP	2021-12-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021356-004	PED	2022-06-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021356-001	NPP	2021-12-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021356-001	PED	2022-06-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021356-002	NPP	2021-12-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021356-002	PED	2022-06-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021356-003	NPP	2021-12-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021356-003	PED	2022-06-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021356-004	NPP	2021-12-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021356-004	PED	2022-06-11	`87673890dc5c…`

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
Viread	TENOFOVIR DISOPROXIL FUMARATE	Gilead Sciences, Inc.	33fd6418-fbdc-42ca-a50d-ce2a476a5418	2025-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021356 application number: NDA021356

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
50090-0754-0	50090075400	30 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-0754-0)	2014-11-28	0000-00-00	No	No	Current