Oseltamivir Phosphate

Product NDC
50090-6099
11-digit product format
500906099
Labeler code
50090
Product ID
50090-6099_041c817b-a338-4062-bfa6-28dcd6a9ab9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209438
Marketing category
ANDA
Marketing start
2018-02-23
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A209438-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-23
A209438-002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-23
A209438-003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209438-001AB
A209438-002AB
A209438-003AB

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 UTC2026-02A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209438-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-02-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209438-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-02-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209438-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-02-238072bd15b7f6…

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 UTC2026-02A209438-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209438-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209438-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209438-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209438-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209438-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209438-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209438-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209438-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209438-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209438-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209438-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209438-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209438-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209438-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209438-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209438-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209438-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209438-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209438-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209438-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209438-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209438-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209438-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209438-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209438-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209438-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209438-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209438-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209438-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209438-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209438-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209438-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209438-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209438-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209438-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209438-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209438-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209438-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209438-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Oseltamivir Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4A3O49NGEZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312122Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0f71ac9-136c-4c8d-b30d-b8d08767c206Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6099-0Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE108
50090-6099-0Oseltamivir Phosphate1 in 1 CARTONCAPSULE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6099-0EA - Each50090-6099d8738dc6-ec3a-4b36-99f3-1b71b12f0f5712022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6099OSELTAMIVIR PHOSPHATE CAPSULE [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20231117_a0f71ac9-136c-4c8d-b30d-b8d08767c206.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATESportpharm LLCa8a40f98-f6bd-4ef0-af03-93ed0f473c102026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209438
application number: ANDA209438
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEREMEDYREPACK INC.ad90fe42-8d52-403e-9b07-b8536fbf335a2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209438
application number: ANDA209438
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEA-S Medication Solutionsa0f71ac9-136c-4c8d-b30d-b8d08767c2062023-11-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209438
application number: ANDA209438
ndc (product): 50090-6099
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEProficient Rx LP8e81aaa7-7c40-4b05-b19a-cc70edd1d9f92023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209438
application number: ANDA209438
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEAsclemed USA, Inc.00be0870-2ebb-46e3-9e98-a8f068ec664a2022-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209438
application number: ANDA209438
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEProficient Rx LP1f754ad7-9df0-4121-8051-0a09491be3c72022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209438
application number: ANDA209438
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEProficient Rx LP8d264c73-4dd9-4f7c-8a18-f31195cdd0132022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209438
application number: ANDA209438
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATECamber Pharmaceuticals, Inc.2a673aa2-e8f0-4aa4-8782-6fb3067ff1082018-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209438
application number: ANDA209438

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSNa0f71ac9-136c-4c8d-b30d-b8d08767c2068
312122oseltamivir 75 MG Oral CapsuleSCDa0f71ac9-136c-4c8d-b30d-b8d08767c2068
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYa0f71ac9-136c-4c8d-b30d-b8d08767c2068

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6099-0500906099001 BLISTER PACK in 1 CARTON (50090-6099-0) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2022-09-230000-00-00NoNoCurrent