Oseltamivir phosphate

Product NDC
53002-3710
11-digit product format
530023710
Labeler code
53002
Product ID
53002-3710_5cfcf41c-7fe1-45d1-8b0f-fcb5173374ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA208348
Marketing category
ANDA
Marketing start
2018-02-09
Marketing end
0000-00-00
Substance
OSELTAMIVIR PHOSPHATE
Active strength
45 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct53002-3710IInactivated by FDA2026-08-17
excluded packagepackage53002-371053002-3710-1IInactivated 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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-3710-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-3710-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-3710-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-3710-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-3710-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-3710-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-3710-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-3710-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-3710-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A208348-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09
A208348-002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09
A208348-003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208348-001AB
A208348-002AB
A208348-003AB

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 06:07:402026-07A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09caaa826d4ba7…
2026-08-18 06:07:402026-07A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09caaa826d4ba7…
2026-08-18 06:07:402026-07A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-091e350fbaab3a…

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 06:07:402026-07A208348-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208348-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208348-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208348-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208348-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208348-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208348-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208348-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208348-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208348-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208348-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208348-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208348-001AB11e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3710-1Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE103
53002-3710-1Oseltamivir phosphate1 in 1 CARTONCAPSULE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3710OSELTAMIVIR PHOSPHATE CAPSULE [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20230609_e33583ad-90b9-4b61-9888-a974cbd5ede8.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oseltamivir phosphateOSELTAMIVIR PHOSPHATEREMEDYREPACK INC.ad765459-e0d2-418e-8bae-8f6d16dfc1d82026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208348
application number: ANDA208348
Oseltamivir phosphateOSELTAMIVIR PHOSPHATELupin Pharmaceuticals, Inc.7dd9f7f2-a887-454a-8d3e-761083b840db2025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208348
application number: ANDA208348
Oseltamivir phosphateOSELTAMIVIR PHOSPHATEPreferred Pharmaceuticals Inc.40312c99-5374-41fa-a687-c70d97445e242025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208348
application number: ANDA208348
Oseltamivir phosphateOSELTAMIVIR PHOSPHATEProficient Rx LPcd0236c6-317c-47b1-9185-3253dba4bb372022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208348
application number: ANDA208348
Oseltamivir phosphateOSELTAMIVIR PHOSPHATEProficient Rx LP196c8dee-342b-4627-b060-39b99ed91a412022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208348
application number: ANDA208348

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728113oseltamivir phosphate 45 MG Oral CapsulePSNe33583ad-90b9-4b61-9888-a974cbd5ede83
728113oseltamivir 45 MG Oral CapsuleSCDe33583ad-90b9-4b61-9888-a974cbd5ede83
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYe33583ad-90b9-4b61-9888-a974cbd5ede83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3710-1530023710011 BLISTER PACK in 1 CARTON (53002-3710-1) > 10 CAPSULE in 1 BLISTER PACK1 blister pack2020-01-010000-00-00NoNoCurrent