oseltamivir phosphate

Product NDC
33342-257
11-digit product format
333420257
Labeler code
33342
Product ID
33342-257_e6722163-0760-4653-bab9-1bb1a603e935
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA207211
Marketing category
ANDA
Marketing start
2017-09-21
Substance
OSELTAMIVIR PHOSPHATE
Active strength
45 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct33342-257EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33342-25733342-257-66EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A207211-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-14
A207211-002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-14
A207211-003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207211-001AB
A207211-002AB
A207211-003AB

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 UTC2026-02A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207211-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2017-09-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207211-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2017-09-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207211-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2017-09-148072bd15b7f6…

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 UTC2026-02A207211-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207211-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207211-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207211-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207211-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207211-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207211-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207211-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207211-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207211-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207211-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207211-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207211-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207211-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207211-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207211-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207211-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207211-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207211-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207211-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207211-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207211-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207211-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207211-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207211-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207211-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207211-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207211-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207211-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207211-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207211-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207211-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207211-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207211-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207211-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207211-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207211-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207211-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207211-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207211-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
oseltamivir phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE45 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
e9307620-36bd-46c2-a8b2-027d3fba87baAvailable 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
33342-257-66oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE107
33342-257-66oseltamivir phosphate01 in 1 CARTONCAPSULE017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-257-66EA - Each33342-257998287a3-51aa-46ad-8c39-c82f779e9f4312018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-257OSELTAMAVIR PHOSPHATE CAPSULE [MACLEODS PHARMACEUTICALS LIMITED]6Current NDC, Legacy NDC, 2 package rows20220906_e9307620-36bd-46c2-a8b2-027d3fba87ba.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oseltamivir phosphateOSELTAMIVIR PHOSPHATEMacleods Pharmaceuticals Limitede9307620-36bd-46c2-a8b2-027d3fba87ba2025-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207211
application number: ANDA207211
ndc (product): 33342-257
oseltamavir phosphateOSELTAMAVIR PHOSPHATENuCare Pharmaceuticals,Inc.80511c6f-88b9-62d3-e053-2991aa0ab9362025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207211
application number: ANDA207211
oseltamavir phosphateOSELTAMAVIR PHOSPHATENuCare Pharmaceuticals, Inc.28ddaeb7-5903-4b59-e063-6294a90a2bcd2024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207211
application number: ANDA207211
oseltamavir phosphateOSELTAMAVIR PHOSPHATEProficient Rx LP09e119eb-a8fa-4635-96a7-1b134593cdca2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207211
application number: ANDA207211
oseltamavir phosphateOSELTAMAVIR PHOSPHATEProficient Rx LPccdb124d-fd56-409a-8615-ae0f675cd8e42020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207211
application number: ANDA207211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSNe9307620-36bd-46c2-a8b2-027d3fba87ba7
728113oseltamivir phosphate 45 MG Oral CapsulePSNe9307620-36bd-46c2-a8b2-027d3fba87ba7
312122oseltamivir phosphate 75 MG Oral CapsulePSNe9307620-36bd-46c2-a8b2-027d3fba87ba7
728109oseltamivir 30 MG Oral CapsuleSCDe9307620-36bd-46c2-a8b2-027d3fba87ba7
728113oseltamivir 45 MG Oral CapsuleSCDe9307620-36bd-46c2-a8b2-027d3fba87ba7
312122oseltamivir 75 MG Oral CapsuleSCDe9307620-36bd-46c2-a8b2-027d3fba87ba7
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSYe9307620-36bd-46c2-a8b2-027d3fba87ba7
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYe9307620-36bd-46c2-a8b2-027d3fba87ba7
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYe9307620-36bd-46c2-a8b2-027d3fba87ba7
728113oseltamivir phosphate 45 MG Oral CapsulePSN28ddaeb7-5903-4b59-e063-6294a90a2bcd1
728113oseltamivir phosphate 45 MG Oral CapsulePSNccdb124d-fd56-409a-8615-ae0f675cd8e41
728113oseltamivir 45 MG Oral CapsuleSCD28ddaeb7-5903-4b59-e063-6294a90a2bcd1
728113oseltamivir 45 MG Oral CapsuleSCDccdb124d-fd56-409a-8615-ae0f675cd8e41
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY28ddaeb7-5903-4b59-e063-6294a90a2bcd1
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYccdb124d-fd56-409a-8615-ae0f675cd8e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-257-66333420257661 BLISTER PACK in 1 CARTON (33342-257-66) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2017-09-210000-00-00NoNoCurrent