Oseltamivir Phosphate

Product NDC
53217-280
11-digit product format
532170280
Labeler code
53217
Product ID
53217-280_b71630b8-6cea-458d-9d81-bc8bd7fcb092
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA202595
Marketing category
ANDA
Marketing start
2016-12-12
Marketing end
0000-00-00
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53217-280IInactivated by FDA2026-08-17
excluded packagepackage53217-28053217-280-01IInactivated by FDA2026-08-17

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 · 42 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 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-280-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-280-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-280-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-280-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-280-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-280-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-280-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-280-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-280-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-280-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-280-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-280-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53217-280-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53217-280-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53217-280-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53217-280-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53217-280-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53217-280-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53217-280-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53217-280-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53217-280-019bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202595-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-03
A202595-002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-03
A202595-003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202595-001AB
A202595-002AB
A202595-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202595-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2016-08-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202595-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2016-08-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202595-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2016-08-031e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202595-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202595-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202595-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202595-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202595-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202595-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202595-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202595-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202595-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202595-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202595-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202595-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202595-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202595-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202595-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202595-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202595-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202595-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202595-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202595-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202595-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202595-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202595-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202595-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202595-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202595-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202595-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202595-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202595-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202595-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202595-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202595-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202595-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202595-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202595-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202595-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202595-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202595-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202595-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202595-001AB11e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-280-01Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE101
53217-280-01Oseltamivir Phosphate1 in 1 CARTONCAPSULE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-280-01EA - Each53217-280e64a20e2-ba4d-4474-a786-3dab619e913012017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-280OSELTAMIVIR PHOSPHATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20170422_394365f1-056d-437c-b46b-dd907a67a9cb.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEA-S Medication Solutionse1bec65b-4292-4110-a840-aa48053b54482026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202595
application number: ANDA202595
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEAlvogen Inc.809f859e-0852-80d3-1a67-da87ed399c152026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202595
application number: ANDA202595

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN394365f1-056d-437c-b46b-dd907a67a9cb1
312122oseltamivir 75 MG Oral CapsuleSCD394365f1-056d-437c-b46b-dd907a67a9cb1
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY394365f1-056d-437c-b46b-dd907a67a9cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-280-015321702800110 in 1 BLISTER PACKHistorical