Oseltamivir Phosphate

Product NDC
50090-4650
Requested package NDC
50090-4650-0
11-digit product format
500904650
Labeler code
50090
Product ID
50090-4650_0625c515-811f-449f-a0c4-a09e3ab6cc61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209093
Marketing category
ANDA
Marketing start
2017-05-21
Marketing end
0000-00-00
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-465050090-4650-0IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A209093-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-17
A209093-002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-17
A209093-003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209093-001AB
A209093-002AB
A209093-003AB

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 UTC2026-02A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209093-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-05-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209093-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-05-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209093-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-05-178072bd15b7f6…

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 UTC2026-02A209093-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209093-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209093-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209093-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209093-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209093-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209093-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209093-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209093-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209093-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209093-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209093-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209093-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209093-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209093-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209093-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209093-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209093-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209093-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209093-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209093-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209093-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209093-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209093-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209093-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209093-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209093-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209093-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209093-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209093-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209093-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209093-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209093-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209093-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209093-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209093-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209093-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209093-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209093-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209093-001AB18072bd15b7f6…

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
50090-4650-0Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE105
50090-4650-0Oseltamivir Phosphate1 in 1 CARTONCAPSULE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4650-0EA - Each50090-4650dde0d6a4-d1cd-4688-b2dc-cfdf161a2c1d12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4650OSELTAMIVIR PHOSPHATE (OSELTAMIVIR) CAPSULE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210417_5445db5c-d262-45f4-9979-b1edcda08d5a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oseltamivir PhosphateOSELTAMIVIRAvKAREc61bb5af-558f-4b32-b34d-8fdae480443c2026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209093
application number: ANDA209093
Oseltamivir PhosphateOSELTAMIVIRAmneal Pharmaceuticals NY LLC8ca926e0-4c3c-473f-9cd0-ff38032d69632023-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209093
application number: ANDA209093
Oseltamivir PhosphateOSELTAMIVIRAmneal Pharmaceuticals NY LLCd306e22c-0cb8-46cb-9a40-8194a2bc9e852022-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209093
application number: ANDA209093

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN5445db5c-d262-45f4-9979-b1edcda08d5a5
312122oseltamivir 75 MG Oral CapsuleSCD5445db5c-d262-45f4-9979-b1edcda08d5a5
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY5445db5c-d262-45f4-9979-b1edcda08d5a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4650-0500904650001 BLISTER PACK in 1 CARTON (50090-4650-0) > 10 CAPSULE in 1 BLISTER PACK1 blister pack2019-10-250000-00-00NoNoCurrent