oseltamavir phosphate

Product NDC
68071-4739
Requested package NDC
68071-4739-1
11-digit product format
680714739
Labeler code
68071
Product ID
68071-4739_2d7d2d42-1baa-e20a-e063-6394a90a15cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamavir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207211
Marketing category
ANDA
Marketing start
2017-09-21
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 · 3 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
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-473968071-4739-1IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-473968071-4739-1IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-473968071-4739-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…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
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
oseltamavir 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
80511c6f-88b9-62d3-e053-2991aa0ab936Available 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
68071-4739-1oseltamavir phosphate10 in 1 BOXCAPSULE105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4739OSELTAMAVIR PHOSPHATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20250209_80511c6f-88b9-62d3-e053-2991aa0ab936.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
oseltamavir phosphateOSELTAMAVIR PHOSPHATENuCare Pharmaceuticals,Inc.80511c6f-88b9-62d3-e053-2991aa0ab9362025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207211
application number: ANDA207211
ndc (package): 68071-4739-1
ndc (product): 68071-4739
ndc11 (package): 68071473901
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
312122oseltamivir phosphate 75 MG Oral CapsulePSN80511c6f-88b9-62d3-e053-2991aa0ab9365
312122oseltamivir 75 MG Oral CapsuleSCD80511c6f-88b9-62d3-e053-2991aa0ab9365
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY80511c6f-88b9-62d3-e053-2991aa0ab9365

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4739-16807147390110 CAPSULE in 1 BOX (68071-4739-1) 10 capsule2019-01-250000-00-00NoNoCurrent