FDA.reportPublic FDA data

Tenofovir Disoproxil Fumarate

Product NDC
65862-421
11-digit product format
658620421
Labeler code
65862
Product ID
65862-421_ab772f55-3f84-41df-a84f-3a7035602cfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tenofovir Disoproxil Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090647
Marketing category
ANDA
Marketing start
2018-01-26
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

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-421UNFINISHEDActive or certified unfinished drug listing2026-08-12
unfinished packagepackage65862-42165862-421-22UNFINISHEDActive or certified unfinished drug listing2026-08-12

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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-421-22a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-421-221d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-421-22390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-421-22e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-421-22bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-421-22f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-421-22f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-421-2268b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-421-2205c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-421-2248b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-421-2227f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-421-228d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-421-22d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-421-2250b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-421-22906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-421-226db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-421-228fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-421-224184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-421-224bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-421-22263afe128892…91768de4ddbe…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090647-001TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26
A090647-002TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26
A090647-003TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26
A090647-004TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090647-001AB
A090647-002AB
A090647-003AB
A090647-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090647-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090647-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090647-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Tenofovir Disoproxil Fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TENOFOVIR DISOPROXIL FUMARATE300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OTT9J7900IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349251Internal RxNorm lookup
1243227Internal RxNorm lookup
1243324Internal RxNorm lookup
1243328Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a75c6be8-3719-4bb3-8a9e-06e5254d2a82Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
5f93de8c-a439-4aaa-862f-7cf2524cb240Product name320250812
6286e356-28a5-4b4b-a174-76bf53b211e3Product name620250121
233e3f87-da6c-4b7d-80cb-963ca3258270Product name220240419
c0c98dbe-5e23-74e9-f9fc-07af05f77d95Product name820240319
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
1cd1fd33-94db-4c45-bd26-82773ea350a3Product name220220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
7fd46899-3505-4ed4-b856-6b2509a76004Product name120151123
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-421-30Tenofovir Disoproxil Fumarate30 in 1 BOTTLETABLET, FILM COATED3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-421-30EA - Each65862-421883d53b1-3d42-49a5-9148-a09522cfdecd12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-421TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]18Current NDC, Legacy NDC, 1 package rows20240608_a75c6be8-3719-4bb3-8a9e-06e5254d2a82.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEAurobindo Pharma Limiteda75c6be8-3719-4bb3-8a9e-06e5254d2a822024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090647
application number: ANDA090647
ndc (product): 65862-421

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243324tenofovir disoproxil fumarate 150 MG Oral TabletPSNa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243328tenofovir disoproxil fumarate 200 MG Oral TabletPSNa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243227tenofovir disoproxil fumarate 250 MG Oral TabletPSNa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSNa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243324tenofovir disoproxil fumarate 150 MG Oral TabletSCDa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243328tenofovir disoproxil fumarate 200 MG Oral TabletSCDa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243227tenofovir disoproxil fumarate 250 MG Oral TabletSCDa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCDa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243324tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral TabletSYa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243328tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral TabletSYa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243227tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral TabletSYa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
349251tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYa75c6be8-3719-4bb3-8a9e-06e5254d2a8218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-421-22658620421222000 TABLET, FILM COATED in 1 BAG (65862-421-22)26-JAN-18Current
65862-421-306586204213030 TABLET, FILM COATED in 1 BOTTLE (65862-421-30) 2018-01-260000-00-00NoNoCurrent