oseltamivir phosphate

Product NDC
72205-060
11-digit product format
722050060
Labeler code
72205
Product ID
72205-060_74403f5d-4764-456b-b2f7-6e6955d68b6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA215313
Marketing category
ANDA
Marketing start
2022-05-06
Substance
OSELTAMIVIR PHOSPHATE
Active strength
6 mg/mL
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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215313-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215313-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-0284e616aacf4f…
2026-08-18 06:07:402026-07A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-025c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215313-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2022-05-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215313-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A215313-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215313-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215313-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215313-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215313-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215313-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215313-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215313-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215313-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215313-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215313-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215313-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215313-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215313-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215313-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215313-001AB15c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215313-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215313-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215313-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215313-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215313-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215313-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215313-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A215313-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A215313-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215313-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215313-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215313-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215313-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215313-001AB1a50c72e98297…

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 PHOSPHATE6 mg/mL

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
1115698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46dda802-32b8-4608-8eae-97e2cfc57472Available 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
72205-060-78oseltamivir phosphate60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-060-78ML - Milliliter72205-0608c2944d1-ae2a-4e16-b2a3-3ab96d6af64a12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-060OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [NOVADOZ PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 1 package rows20241122_46dda802-32b8-4608-8eae-97e2cfc57472.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 PHOSPHATENovadoz Pharmaceuticals LLC46dda802-32b8-4608-8eae-97e2cfc574722022-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215313
application number: ANDA215313
ndc (product): 72205-060

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN46dda802-32b8-4608-8eae-97e2cfc574724
1115698oseltamivir 6 MG/ML Oral SuspensionSCD46dda802-32b8-4608-8eae-97e2cfc574724
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY46dda802-32b8-4608-8eae-97e2cfc574724
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY46dda802-32b8-4608-8eae-97e2cfc574724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-060-787220500607860 mL in 1 BOTTLE, GLASS (72205-060-78) 60 ml2022-05-060000-00-00NoNoCurrent