Oseltamivir Phosphate

Product NDC
0093-8180
11-digit product format
000938180
Labeler code
0093
Product ID
0093-8180_f8f3e33e-61de-4fe8-9a9b-11404ab66ded
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA211125
Marketing category
ANDA
Marketing start
2019-07-10
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
A211125-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211125-001AB

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 UTC2026-02A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-273f01610625f2…
2019-09-15 20:21 UTC2019-09A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211125-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2019-02-27cb3db0bc1861…

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 UTC2026-02A211125-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211125-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211125-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211125-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211125-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211125-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211125-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211125-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211125-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211125-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211125-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211125-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211125-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211125-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211125-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211125-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211125-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211125-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211125-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211125-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211125-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211125-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211125-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211125-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211125-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A211125-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211125-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211125-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211125-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211125-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211125-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211125-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211125-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211125-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211125-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211125-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211125-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211125-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211125-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211125-001AB1cb3db0bc1861…

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
3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-8180-64Oseltamivir Phosphate1 in 1 CARTONPOWDER, FOR SUSPENSION15
0093-8180-64Oseltamivir Phosphate60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8180-64ML - Milliliter0093-8180c1efc242-a76b-4bba-963f-63ab30d23cf812019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8180OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA, INC.]4Current NDC, Legacy NDC, 2 package rows20221020_3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATETeva Pharmaceuticals USA, Inc.3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b2025-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211125
application number: ANDA211125
ndc (product): 0093-8180
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEA-S Medication Solutions73d7fa5a-8304-44b7-9456-58926a265d812023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211125
application number: ANDA211125

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN73d7fa5a-8304-44b7-9456-58926a265d816
1115698oseltamivir 6 MG/ML Oral SuspensionSCD73d7fa5a-8304-44b7-9456-58926a265d816
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY73d7fa5a-8304-44b7-9456-58926a265d816
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY73d7fa5a-8304-44b7-9456-58926a265d816
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b5
1115698oseltamivir 6 MG/ML Oral SuspensionSCD3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b5
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b5
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-8180-64000938180641 BOTTLE in 1 CARTON (0093-8180-64) / 60 mL in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent