Oseltamivir Phosphate

Product NDC
68071-2565
11-digit product format
680712565
Labeler code
68071
Product ID
68071-2565_cffe01a3-cd43-3ff2-e053-2995a90adc02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209421
Marketing category
ANDA
Marketing start
2018-10-05
Marketing end
0000-00-00
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct68071-2565IInactivated by FDA2026-08-07
excluded packagepackage68071-256568071-2565-1IInactivated by FDA2026-08-07

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 packagepackage68071-2565-1IInactivated 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 packagepackage68071-2565-1IInactivated 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 packagepackage68071-2565-1IInactivated 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 packagepackage68071-2565-1IInactivated 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 packagepackage68071-2565-1IInactivated 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 packagepackage68071-2565-1IInactivated 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 packagepackage68071-2565-1UExcluded 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 packagepackage68071-2565-1UExcluded 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 packagepackage68071-2565-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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

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
A209421-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-08
A209421-002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-08
A209421-003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209421-001AB
A209421-002AB
A209421-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209421-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-06-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209421-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209421-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-06-088072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209421-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209421-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209421-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209421-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209421-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209421-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209421-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209421-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209421-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209421-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209421-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209421-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209421-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209421-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209421-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209421-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209421-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209421-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209421-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209421-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209421-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209421-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209421-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209421-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209421-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209421-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209421-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209421-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209421-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209421-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209421-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209421-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209421-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209421-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209421-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209421-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209421-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209421-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209421-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209421-001AB18072bd15b7f6…

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
68071-2565-1Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2565OSELTAMIVIR PHOSPHATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20230718_cffe01a3-cd42-3ff2-e053-2995a90adc02.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATESportpharm LLC92726a00-4237-49fd-9e29-5d4f5f9998742026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209421
application number: ANDA209421
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEPreferred Pharmaceuticals Inc.89a3539b-a067-4073-b7a0-d04e7f1303962025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209421
application number: ANDA209421
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEA-S Medication Solutions91eadf0b-5f04-4f5d-b095-02c5736a36472023-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209421
application number: ANDA209421
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEAsclemed USA, Inc.78f85d27-9935-4775-b8d7-275e11429b762023-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209421
application number: ANDA209421
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEStrides Pharma Science Limitedf26154bd-374c-44a8-983a-b2724a5916532022-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209421
application number: ANDA209421
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEProficient Rx LPde553d49-38c3-4fad-8582-d4d27c3c26b12022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209421
application number: ANDA209421

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSNcffe01a3-cd42-3ff2-e053-2995a90adc022
312122oseltamivir 75 MG Oral CapsuleSCDcffe01a3-cd42-3ff2-e053-2995a90adc022
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYcffe01a3-cd42-3ff2-e053-2995a90adc022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2565-16807125650110 CAPSULE in 1 BLISTER PACK (68071-2565-1) 10 capsule2021-11-040000-00-00NoNoCurrent