Tenofovir Disoproxil Fumarate

Product NDC: 42385-901
11-digit product format: 423850901
Labeler code: 42385
Product ID: 42385-901_758c6876-348f-4c8a-a814-e811621ebd18
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tenofovir Disoproxil Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Laurus Labs Limited
Application: ANDA209550
Marketing category: ANDA
Marketing start: 2018-02-26
Marketing end: 0000-00-00
Substance: TENOFOVIR DISOPROXIL FUMARATE
Active strength: 300 mg/1
Pharmacologic classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42385-901		I	Inactivated by FDA	2026-08-11
excluded package	package	42385-901	42385-901-03	I	Inactivated by FDA	2026-08-11
excluded package	package	42385-901	42385-901-50	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 2 · 63 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	42385-901-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42385-901-50	`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	42385-901-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42385-901-50	`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	42385-901-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42385-901-50	`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	42385-901-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42385-901-50	`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	42385-901-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42385-901-50	`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	42385-901-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42385-901-50	`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	42385-901-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42385-901-50	`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	42385-901-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42385-901-50	`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	42385-901-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42385-901-50	`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	42385-901-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42385-901-50	`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	42385-901-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42385-901-50	`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	42385-901-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42385-901-50	`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	42385-901-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42385-901-50	`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	42385-901-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42385-901-50	`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	42385-901-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42385-901-50	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42385-901-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42385-901-50	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42385-901-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42385-901-50	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42385-901-03	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42385-901-50	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42385-901-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42385-901-50	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42385-901-03	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42385-901-50	`e2bbac7714bc…`	`27bdfed8d636…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209550-001	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL			2018-02-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL		2018-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209550-001	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-02-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209550-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209550-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209550-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209550-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209550-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209550-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209550-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209550-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209550-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209550-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209550-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209550-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209550-001	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209550-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209550-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209550-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209550-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209550-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209550-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209550-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209550-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209550-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209550-001	AB	1	`cb3db0bc1861…`

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
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
42385-901-03	2020-01-31	C162847	48780-1	9d75b9d0-965e-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for TENOFOVIR DISOPROXIL FUMARATE TABLETS. TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use Initial U.S. Approval: 2001
42385-901-50	2020-01-31	C162847	48780-1	9d75b9d0-965e-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for TENOFOVIR DISOPROXIL FUMARATE TABLETS. TENOFOVIR DISOPROXIL FUMARATE tablets, 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
42385-901-03	Tenofovir Disoproxil Fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30		1
42385-901-50	Tenofovir Disoproxil Fumarate	500 in 1 BOTTLE	TABLET, FILM COATED	500		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42385-901-03	EA - Each	42385-901	7598dd06-b9dc-41ce-b7cc-9974df5198c2	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42385-901	TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [LAURUS LABS LIMITED]	1	Legacy NDC, 2 package rows	20180228_758c6876-348f-4c8a-a814-e811621ebd18.zip

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	758c6876-348f-4c8a-a814-e811621ebd18	1
349251	tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	758c6876-348f-4c8a-a814-e811621ebd18	1
349251	tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	758c6876-348f-4c8a-a814-e811621ebd18	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42385-901-03	42385090103	30 in 1 BOTTLE	Historical
42385-901-50	42385090150	500 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tenofovir Disoproxil Fumarate	Laurus Labs Limited \| Laurus Labs Limited (VSP2)	2018-02-26	Human Prescription Drug Label	1