Viread

Product NDC: 61958-0401
11-digit product format: 619580401
Labeler code: 61958
Product ID: 61958-0401_1b2267fa-9978-4429-ac13-09a5d43b3093
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TENOFOVIR DISOPROXIL FUMARATE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Gilead Sciences, Inc.
Application: NDA021356
Marketing category: NDA
Marketing start: 2001-10-26
Substance: TENOFOVIR DISOPROXIL FUMARATE
Active strength: 300 mg/1
Pharmacologic classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 6 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
2025-02-02 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	61958-0401-1	`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	61958-0401-1	`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	61958-0401-1	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Viread
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TENOFOVIR DISOPROXIL FUMARATE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OTT9J7900I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349251	Internal RxNorm lookup
352050	Internal RxNorm lookup
1243227	Internal RxNorm lookup
1243229	Internal RxNorm lookup
1243324	Internal RxNorm lookup
1243326	Internal RxNorm lookup
1243328	Internal RxNorm lookup
1243330	Internal RxNorm lookup
1243343	Internal RxNorm lookup
1243346	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
33fd6418-fbdc-42ca-a50d-ce2a476a5418	Available on FDA.report

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
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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61958-0401-1	2025-02-20	C162847	48780-1	2cef2736-ab35-d83d-e063-dadaa90ab31f	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) tablets, for oral use VIREAD ® (tenofovir disoproxil fumarate) powder, for oral use Initial U.S. Approval: 2001
61958-0401-1	2025-01-30	C162847	48780-1	2cef2736-ab35-d83d-e063-dadaa90ab31f	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) tablets, for oral use VIREAD ® (tenofovir disoproxil fumarate) powder, 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
61958-0401-1	Viread	30 in 1 BOTTLE, PLASTIC	TABLET, COATED	30		31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61958-0401-1	EA - Each	61958-0401	59b65336-9b7b-42fb-a051-bf2e2fa4ab7a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TENOFOVIR DISOPROXIL FUMARATE	ACTIVE INGREDIENT	OTT9J7900I	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
TENOFOVIR ANHYDROUS	ACTIVE MOIETY	W4HFE001U5	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
HYPROMELLOSE 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	22
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
61958-0401	VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]	31	Current NDC, Legacy NDC, 1 package rows	20250223_33fd6418-fbdc-42ca-a50d-ce2a476a5418.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 ndc (product): 61958-0401

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
1243324	tenofovir disoproxil fumarate 150 MG Oral Tablet	PSN	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243328	tenofovir disoproxil fumarate 200 MG Oral Tablet	PSN	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243227	tenofovir disoproxil fumarate 250 MG Oral Tablet	PSN	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
349251	tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243343	tenofovir disoproxil fumarate 40 MG/GM Oral Powder	PSN	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243326	Viread 150 MG Oral Tablet	PSN	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243330	Viread 200 MG Oral Tablet	PSN	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243229	Viread 250 MG Oral Tablet	PSN	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
352050	Viread 300 MG Oral Tablet	PSN	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243346	Viread 40 MG/GM Oral Powder	PSN	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243346	tenofovir disoproxil fumarate 0.04 MG/MG Oral Powder [Viread]	SBD	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243326	tenofovir disoproxil fumarate 150 MG Oral Tablet [Viread]	SBD	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243330	tenofovir disoproxil fumarate 200 MG Oral Tablet [Viread]	SBD	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243229	tenofovir disoproxil fumarate 250 MG Oral Tablet [Viread]	SBD	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
352050	tenofovir disoproxil fumarate 300 MG Oral Tablet [Viread]	SBD	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243343	tenofovir disoproxil fumarate 0.04 MG/MG Oral Powder	SCD	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243324	tenofovir disoproxil fumarate 150 MG Oral Tablet	SCD	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243328	tenofovir disoproxil fumarate 200 MG Oral Tablet	SCD	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243227	tenofovir disoproxil fumarate 250 MG Oral Tablet	SCD	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
349251	tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243324	tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243328	tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243227	tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
349251	tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243343	tenofovir disoproxil fumarate 40 MG (equivalent to tenofovir disoproxil 33 MG) per GM Oral Powder	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243343	tenofovir disoproxil fumarate 40 MG per GM Oral Powder	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243346	Viread 0.04 MG/MG Oral Powder	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243326	Viread 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243326	Viread 150 MG Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243330	Viread 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243330	Viread 200 MG Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243229	Viread 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243229	Viread 250 MG Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
352050	Viread 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
352050	Viread 300 MG Oral Tablet	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243346	Viread 40 MG (equivalent to tenofovir disoproxil 33 MG) per GM Oral Powder	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
1243346	Viread 40 MG per GM Oral Powder	SY	33fd6418-fbdc-42ca-a50d-ce2a476a5418	31
349251	tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	d3d0b5ef-8226-49d6-ab66-987943413ccc	1
349251	tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	e122435e-cd0b-4c90-940a-b7a0d090d866	1
352050	Viread 300 MG Oral Tablet	PSN	d3d0b5ef-8226-49d6-ab66-987943413ccc	1
352050	Viread 300 MG Oral Tablet	PSN	e122435e-cd0b-4c90-940a-b7a0d090d866	1
352050	tenofovir disoproxil fumarate 300 MG Oral Tablet [Viread]	SBD	d3d0b5ef-8226-49d6-ab66-987943413ccc	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	d3d0b5ef-8226-49d6-ab66-987943413ccc	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	d3d0b5ef-8226-49d6-ab66-987943413ccc	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 (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	d3d0b5ef-8226-49d6-ab66-987943413ccc	1
352050	Viread 300 MG Oral Tablet	SY	e122435e-cd0b-4c90-940a-b7a0d090d866	1
352050	Viread 300 MG Oral Tablet	SY	d3d0b5ef-8226-49d6-ab66-987943413ccc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61958-0401-1	61958040101	30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0401-1)	2001-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Viread	Gilead Sciences, Inc.	2025-02-18	HUMAN PRESCRIPTION DRUG LABEL	31
Viread	REMEDYREPACK INC.	2020-04-07	HUMAN PRESCRIPTION DRUG LABEL	4
Viread	A-S Medication Solutions	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	8
Viread	Avera McKennan Hospital	2015-11-24	HUMAN PRESCRIPTION DRUG LABEL	1
Viread	State of Florida DOH Central Pharmacy	2010-04-13	HUMAN PRESCRIPTION DRUG LABEL	1