Oseltamivir Phosphate for Oral Suspension

Product NDC
68071-3724
11-digit product format
680713724
Labeler code
68071
Product ID
68071-3724_2774401f-7aa8-3087-e063-6294a90a240d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208823
Marketing category
ANDA
Marketing start
2017-11-01
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
A208823-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208823-001AB

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 UTC2026-02A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-313f01610625f2…
2019-09-15 20:21 UTC2019-09A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208823-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2017-10-31cb3db0bc1861…

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 UTC2026-02A208823-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208823-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208823-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208823-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208823-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208823-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208823-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208823-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208823-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208823-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208823-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208823-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208823-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208823-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208823-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208823-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208823-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208823-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208823-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208823-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208823-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208823-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208823-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208823-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208823-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208823-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208823-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208823-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208823-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208823-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208823-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208823-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208823-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208823-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208823-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208823-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208823-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208823-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208823-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208823-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Oseltamivir Phosphate for Oral Suspension
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
27745acb-69a3-a1af-e063-6394a90ab10fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3724-6Oseltamivir Phosphate for Oral Suspension1 in 1 CARTONPOWDER, FOR SUSPENSION11
68071-3724-6Oseltamivir Phosphate for Oral Suspension60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3724OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 2 package rows20241123_27745acb-69a3-a1af-e063-6394a90ab10f.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 Phosphate for Oral SuspensionOSELTAMIVIR PHOSPHATEAlvogen Inc.82df3237-636b-7bf9-3ba0-2b476e74bf4c2025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208823
application number: ANDA208823
Oseltamivir Phosphate for Oral SuspensionOSELTAMIVIR PHOSPHATENuCare Pharmaceuticals,Inc.27745acb-69a3-a1af-e063-6394a90ab10f2024-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208823
application number: ANDA208823
ndc (product): 68071-3724

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN27745acb-69a3-a1af-e063-6394a90ab10f1
1115698oseltamivir 6 MG/ML Oral SuspensionSCD27745acb-69a3-a1af-e063-6394a90ab10f1
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY27745acb-69a3-a1af-e063-6394a90ab10f1
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY27745acb-69a3-a1af-e063-6394a90ab10f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3724-6680713724061 BOTTLE, GLASS in 1 CARTON (68071-3724-6) / 60 mL in 1 BOTTLE, GLASS2024-11-21NoNoCurrent