Viread

Product NDC: 53808-0810
11-digit product format: 538080810
Labeler code: 53808
Product ID: 53808-0810_bea0f43d-4f45-40d2-b4a4-3ac996bb1626
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tenofovir disoproxil fumarate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: NDA021356
Marketing category: NDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: TENOFOVIR DISOPROXIL FUMARATE
Active strength: 300 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
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	53808-0810		I	Inactivated by FDA		2026-08-11
excluded package	package	53808-0810	53808-0810-1	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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0810-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0810-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0810-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0810-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0810-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0810-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0810-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0810-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0810-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0810-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0810-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0810-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0810-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0810-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0810-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0810-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0810-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0810-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0810-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0810-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0810-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0810-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33cd1557-9629-1a35-1f2f-499cf7c608bc	Product name	2	20260305
6286e356-28a5-4b4b-a174-76bf53b211e3	Product name	6	20250121
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
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
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
53808-0810-1	2020-01-31	C162847	48780-1	9d75b9d0-2a88-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use VIREAD safely and effectively. See full prescribing information for VIREAD. VIREAD (tenofovir disoproxil fumarate) tablet, coated for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0810-1	Viread	30 in 1 BLISTER PACK	TABLET, COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
TENOFOVIR DISOPROXIL FUMARATE	ACTIVE INGREDIENT	OTT9J7900I	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
tenofovir	ACTIVE MOIETY	99YXE507IL	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0810	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100415_e122435e-cd0b-4c90-940a-b7a0d090d866.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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349251	tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	e122435e-cd0b-4c90-940a-b7a0d090d866	1
352050	Viread 300 MG Oral Tablet	PSN	e122435e-cd0b-4c90-940a-b7a0d090d866	1
352050	tenofovir disoproxil fumarate 300 MG Oral Tablet [Viread]	SBD	e122435e-cd0b-4c90-940a-b7a0d090d866	1
349251	tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	e122435e-cd0b-4c90-940a-b7a0d090d866	1
349251	tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	e122435e-cd0b-4c90-940a-b7a0d090d866	1
352050	Viread 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	e122435e-cd0b-4c90-940a-b7a0d090d866	1
352050	Viread 300 MG Oral Tablet	SY	e122435e-cd0b-4c90-940a-b7a0d090d866	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0810-1	53808081001	30 in 1 BLISTER PACK	Historical