OSELTAMIVIR PHOSPHATE

Product NDC
67296-1923
11-digit product format
672961923
Labeler code
67296
Product ID
67296-1923_4727cea0-395f-79fb-e063-6394a90a5364
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA208578
Marketing category
ANDA
Marketing start
2017-02-24
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
A208578-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-24
A208578-002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-24
A208578-003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208578-001AB
A208578-002AB
A208578-003AB

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 UTC2026-02A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208578-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-02-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208578-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-02-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208578-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-02-248072bd15b7f6…

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 UTC2026-02A208578-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208578-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208578-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208578-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208578-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208578-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208578-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208578-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208578-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208578-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208578-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208578-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208578-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208578-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208578-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208578-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208578-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208578-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208578-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208578-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208578-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208578-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208578-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208578-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208578-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208578-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208578-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208578-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208578-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208578-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208578-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208578-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208578-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208578-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208578-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208578-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208578-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208578-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208578-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208578-001AB18072bd15b7f6…

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
2fbd0c56-82bf-f0fa-e063-6294a90a9f2fAvailable 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
67296-1923-1OSELTAMIVIR PHOSPHATE1 in 1 CARTONCAPSULE13
67296-1923-1OSELTAMIVIR PHOSPHATE10 in 1 BLISTER PACKCAPSULE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1923OSELTAMIVIR PHOSPHATE CAPSULE [REDPHARM DRUG]1Current NDC, 2 package rows20250309_2fbd0c56-82bf-f0fa-e063-6294a90a9f2f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEPreferred Pharmaceuticals Inc.9dac3ba2-b667-4081-9395-8db45d38ceac2026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208578
application number: ANDA208578
OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATERedpharm Drug2fbd0c56-82bf-f0fa-e063-6294a90a9f2f2025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208578
application number: ANDA208578
ndc (product): 67296-1923
OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEZydus Lifesciences Limited58118069-cb24-4fa3-92d7-cabdc1b027f22024-12-03Exact identifier
application applno (ANDA): 208578
application number: ANDA208578
OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEZydus Pharmaceuticals USA Inc.0e666061-1bfd-48cd-896b-ded8298a18472022-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208578
application number: ANDA208578

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN2fbd0c56-82bf-f0fa-e063-6294a90a9f2f3
312122oseltamivir 75 MG Oral CapsuleSCD2fbd0c56-82bf-f0fa-e063-6294a90a9f2f3
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY2fbd0c56-82bf-f0fa-e063-6294a90a9f2f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-1923-1672961923011 BLISTER PACK in 1 CARTON (67296-1923-1) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2017-02-24NoNoCurrent