oseltamavir phosphate

Product NDC
71205-107
11-digit product format
712050107
Labeler code
71205
Product ID
71205-107_53f50747-996a-4fc1-aad4-4353834514af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamavir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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

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
09e119eb-a8fa-4635-96a7-1b134593cdcaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-107-10oseltamavir phosphate10 in 1 BLISTER PACKCAPSULE105
71205-107-30oseltamavir phosphate30 in 1 BLISTER PACKCAPSULE305
71205-107-60oseltamavir phosphate60 in 1 BLISTER PACKCAPSULE605
71205-107-90oseltamavir phosphate90 in 1 BLISTER PACKCAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-107-10EA - Each71205-107546fea50-9c32-4082-afc5-c3b2028bd31c12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-107OSELTAMAVIR PHOSPHATE CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20221110_09e119eb-a8fa-4635-96a7-1b134593cdca.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
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
ndc (product): 71205-107
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 CapsulePSN09e119eb-a8fa-4635-96a7-1b134593cdca5
312122oseltamivir 75 MG Oral CapsuleSCD09e119eb-a8fa-4635-96a7-1b134593cdca5
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY09e119eb-a8fa-4635-96a7-1b134593cdca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-107-107120501071010 CAPSULE in 1 BLISTER PACK (71205-107-10) 10 capsule2018-09-040000-00-00NoNoCurrent
71205-107-307120501073030 CAPSULE in 1 BLISTER PACK (71205-107-30) 30 capsule2018-09-040000-00-00NoNoCurrent
71205-107-607120501076060 CAPSULE in 1 BLISTER PACK (71205-107-60) 60 capsule2018-09-040000-00-00NoNoCurrent
71205-107-907120501079090 CAPSULE in 1 BLISTER PACK (71205-107-90) 90 capsule2018-09-040000-00-00NoNoCurrent