Oseltamivir Phosphate

Product NDC
69238-1273
11-digit product format
692381273
Labeler code
69238
Product ID
69238-1273_6d430d46-b7a8-4830-ab9f-7b0f234f6829
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210186
Marketing category
ANDA
Marketing start
2018-03-05
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
A210186-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORAL2018-02-27

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 UTC2026-02A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-273f01610625f2…
2019-09-15 20:21 UTC2019-09A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210186-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2018-02-27cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210186-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210186-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210186-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210186-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210186-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210186-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210186-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210186-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210186-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210186-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210186-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210186-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210186-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210186-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210186-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210186-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210186-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210186-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210186-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210186-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210186-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210186-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210186-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210186-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210186-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A210186-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210186-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210186-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210186-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210186-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210186-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210186-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210186-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210186-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210186-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210186-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210186-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210186-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210186-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210186-001AB1cb3db0bc1861…

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
c1a280d0-4ce9-494a-9924-eb5621ce3757Available 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
69238-1273-6Oseltamivir Phosphate60 mL in 1 BOTTLE, GLASSFOR SUSPENSION6022
69238-1273-6Oseltamivir Phosphate1 in 1 CARTONFOR SUSPENSION122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1273-6ML - Milliliter69238-127314e27fad-7d9b-4126-8d55-fae5d2a4754f12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1273OSELTAMIVIR PHOSPHATE FOR SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC]22Current NDC, Legacy NDC, 2 package rows20250427_c1a280d0-4ce9-494a-9924-eb5621ce3757.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 PHOSPHATEAvKARE7d8ce967-8037-9fd5-e053-2991aa0a015f2026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210186
application number: ANDA210186
Oseltamivir PhosphateOSELTAMIVIR PHOSPHATEAmneal Pharmaceuticals NY LLCc1a280d0-4ce9-494a-9924-eb5621ce37572022-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210186
application number: ANDA210186
ndc (product): 69238-1273

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSNc1a280d0-4ce9-494a-9924-eb5621ce375722
1115698oseltamivir 6 MG/ML Oral SuspensionSCDc1a280d0-4ce9-494a-9924-eb5621ce375722
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSYc1a280d0-4ce9-494a-9924-eb5621ce375722
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSYc1a280d0-4ce9-494a-9924-eb5621ce375722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1273-6692381273061 BOTTLE, GLASS in 1 CARTON (69238-1273-6) / 60 mL in 1 BOTTLE, GLASS2018-03-050000-00-00NoNoCurrent