OSELTAMIVIR PHOSPHATE

Product NDC
76282-704
11-digit product format
762820704
Labeler code
76282
Product ID
76282-704_89fabbee-3f3a-4ca4-b53e-4a7eb354c333
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OSELTAMIVIR PHOSPHATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA217467
Marketing category
ANDA
Marketing start
2023-12-01
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

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76282-704-45IInactivated 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 packagepackage76282-704-45IInactivated 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 packagepackage76282-704-45IInactivated 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 packagepackage76282-704-45IInactivated 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 packagepackage76282-704-45IInactivated 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 packagepackage76282-704-45UExcluded 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 packagepackage76282-704-45UExcluded 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 packagepackage76282-704-45UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A217467-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-03
A217467-002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-03
A217467-003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217467-001AB
A217467-002AB
A217467-003AB

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 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-0384e616aacf4f…
2026-09-14 22:38:342026-08A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-0384e616aacf4f…
2026-09-14 22:38:342026-08A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-0384e616aacf4f…
2026-08-18 06:07:402026-07A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217467-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2023-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217467-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2023-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217467-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2023-10-03301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217467-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217467-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217467-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217467-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217467-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217467-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217467-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217467-003AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217467-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217467-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217467-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217467-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217467-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217467-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217467-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217467-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217467-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217467-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217467-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217467-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217467-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217467-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217467-003AB19b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217467-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217467-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217467-003AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312122Internal RxNorm lookup
728109Internal RxNorm lookup
728113Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31c90a2e-9d14-4236-8dc2-b2a862e8cbacAvailable on FDA.report

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
76282-704-45OSELTAMIVIR PHOSPHATE10 in 1 BLISTER PACKCAPSULE102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-704-45EA - Each76282-704d2e0a7d6-899f-448b-a996-c1fbe5de20d012024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-704OSELTAMIVIR PHOSPHATE CAPSULE [EXELAN PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20231209_31c90a2e-9d14-4236-8dc2-b2a862e8cbac.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEExelan Pharmaceuticals, Inc.31c90a2e-9d14-4236-8dc2-b2a862e8cbac2025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217467
application number: ANDA217467
ndc (product): 76282-704

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
728113oseltamivir phosphate 45 MG Oral CapsulePSN31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
312122oseltamivir phosphate 75 MG Oral CapsulePSN31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
728109oseltamivir 30 MG Oral CapsuleSCD31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
728113oseltamivir 45 MG Oral CapsuleSCD31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
312122oseltamivir 75 MG Oral CapsuleSCD31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY31c90a2e-9d14-4236-8dc2-b2a862e8cbac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-704-457628207044510 CAPSULE in 1 BLISTER PACK (76282-704-45) 10 capsule2023-12-01NoNoCurrent