Oseltamivir phosphate

Product NDC
72205-044
Requested package NDC
72205-044-11
11-digit product format
722050044
Labeler code
72205
Product ID
72205-044_2944614f-d7c8-461e-8bcd-373feb20ea4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA212544
Marketing category
ANDA
Marketing start
2020-08-25
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A212544-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-20
A212544-002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-20
A212544-003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212544-001AB
A212544-002AB
A212544-003AB

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 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212544-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2020-05-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212544-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2020-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212544-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2020-05-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212544-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212544-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212544-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212544-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212544-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212544-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212544-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212544-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212544-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212544-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212544-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212544-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212544-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212544-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212544-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212544-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212544-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212544-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212544-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212544-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212544-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212544-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212544-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212544-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212544-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212544-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212544-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212544-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212544-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212544-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212544-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212544-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212544-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212544-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212544-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212544-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212544-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212544-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212544-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212544-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Oseltamivir phosphate
Listing expiration
2027-12-31

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
c456f293-daf7-46b1-bffc-5ca234adbb70Available 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
72205-044-11Oseltamivir phosphate1 in 1 CARTONCAPSULE13
72205-044-11Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-044-11EA - Each72205-044f45918e1-d1aa-4a51-9d41-53664e91bc4512020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-044OSELTAMIVIR PHOSPHATE CAPSULE [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20221206_c456f293-daf7-46b1-bffc-5ca234adbb70.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 PHOSPHATENovadoz Pharmaceuticals LLCc456f293-daf7-46b1-bffc-5ca234adbb702026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212544
application number: ANDA212544
ndc (package): 72205-044-11
ndc (product): 72205-044
ndc11 (package): 72205004411
Oseltamivir phosphateOSELTAMIVIR PHOSPHATEMSN LABORATORIES PRIVATE LIMITED1b7a02ca-ee0e-4853-91e6-71a79f2bc0402025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212544
application number: ANDA212544
Oseltamivir phosphateOSELTAMIVIR PHOSPHATEPreferred Pharmaceuticals Inc.817f74ca-2b6d-4d29-8dd5-b96921a23b912025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212544
application number: ANDA212544
Oseltamivir phosphateOSELTAMIVIR PHOSPHATEProficient Rx LP37eb95bb-3142-4355-8057-4e7c784436412024-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212544
application number: ANDA212544

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN817f74ca-2b6d-4d29-8dd5-b96921a23b914
312122oseltamivir 75 MG Oral CapsuleSCD817f74ca-2b6d-4d29-8dd5-b96921a23b914
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY817f74ca-2b6d-4d29-8dd5-b96921a23b914
728109oseltamivir phosphate 30 MG Oral CapsulePSNc456f293-daf7-46b1-bffc-5ca234adbb703
728113oseltamivir phosphate 45 MG Oral CapsulePSNc456f293-daf7-46b1-bffc-5ca234adbb703
312122oseltamivir phosphate 75 MG Oral CapsulePSNc456f293-daf7-46b1-bffc-5ca234adbb703
728109oseltamivir 30 MG Oral CapsuleSCDc456f293-daf7-46b1-bffc-5ca234adbb703
728113oseltamivir 45 MG Oral CapsuleSCDc456f293-daf7-46b1-bffc-5ca234adbb703
312122oseltamivir 75 MG Oral CapsuleSCDc456f293-daf7-46b1-bffc-5ca234adbb703
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSYc456f293-daf7-46b1-bffc-5ca234adbb703
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYc456f293-daf7-46b1-bffc-5ca234adbb703
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYc456f293-daf7-46b1-bffc-5ca234adbb703
312122oseltamivir phosphate 75 MG Oral CapsulePSN37eb95bb-3142-4355-8057-4e7c784436411
312122oseltamivir phosphate 75 MG Oral CapsulePSNd4dd4b16-1f08-f837-e053-2995a90acd301
312122oseltamivir phosphate 75 MG Oral CapsulePSN1e193419-ece4-8d68-e063-6294a90a17901
312122oseltamivir 75 MG Oral CapsuleSCDd4dd4b16-1f08-f837-e053-2995a90acd301
312122oseltamivir 75 MG Oral CapsuleSCD1e193419-ece4-8d68-e063-6294a90a17901
312122oseltamivir 75 MG Oral CapsuleSCD37eb95bb-3142-4355-8057-4e7c784436411
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY37eb95bb-3142-4355-8057-4e7c784436411
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1e193419-ece4-8d68-e063-6294a90a17901
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYd4dd4b16-1f08-f837-e053-2995a90acd301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-044-11722050044111 BLISTER PACK in 1 CARTON (72205-044-11) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2020-08-250000-00-00NoNoCurrent