Oseltamivir Phosphate

Product NDC
50090-4188
11-digit product format
500904188
Labeler code
50090
Product ID
50090-4188_18da07a0-8914-4e1a-9196-1ac023659e3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208347
Marketing category
ANDA
Marketing start
2018-02-21
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 1.

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
A208347-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208347-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-203f01610625f2…
2019-09-15 20:21 UTC2019-09A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208347-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-20cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208347-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208347-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208347-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208347-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208347-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208347-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208347-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208347-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208347-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208347-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208347-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208347-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208347-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208347-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208347-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208347-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208347-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208347-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208347-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208347-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208347-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208347-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208347-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208347-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208347-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208347-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208347-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208347-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208347-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208347-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208347-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208347-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208347-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208347-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208347-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208347-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208347-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208347-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208347-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208347-001AB1cb3db0bc1861…

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
5194bb90-0876-48c4-a967-c862fbccd110Available 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
50090-4188-0Oseltamivir Phosphate60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION605
50090-4188-0Oseltamivir Phosphate1 in 1 CARTONPOWDER, FOR SUSPENSION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4188-0ML - Milliliter50090-4188b60b1504-819b-430c-b363-0b11ace4146112022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4188OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230708_5194bb90-0876-48c4-a967-c862fbccd110.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 PHOSPHATELupin Pharmaceuticals, Inc.b428e1f2-0082-4d9f-908e-e3633ea0457b2025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208347
application number: ANDA208347
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEAsclemed USA, Inc.d9902b17-389b-45d4-b02f-67e35b0a5f3e2025-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208347
application number: ANDA208347
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEA-S Medication Solutions5194bb90-0876-48c4-a967-c862fbccd1102023-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208347
application number: ANDA208347
ndc (product): 50090-4188
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEProficient Rx LPc754c2f7-7109-4498-aeee-c8ee088dfa982022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208347
application number: ANDA208347

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN5194bb90-0876-48c4-a967-c862fbccd1105
1115698oseltamivir 6 MG/ML Oral SuspensionSCD5194bb90-0876-48c4-a967-c862fbccd1105
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY5194bb90-0876-48c4-a967-c862fbccd1105
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY5194bb90-0876-48c4-a967-c862fbccd1105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4188-0500904188001 BOTTLE, GLASS in 1 CARTON (50090-4188-0) / 60 mL in 1 BOTTLE, GLASS2019-03-140000-00-00NoNoCurrent