Home NDC 72303-0851-1 Oseltamivir Phosphate
Product NDC 72303-0851
Requested package NDC 72303-0851-1
11-digit product format 723030851
Labeler code 72303
Product ID 72303-0851_4dd92187-7139-eadf-e063-6394a90a8329
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oseltamivir phosphate
Dosage form SUSPENSION
Route ORAL
Labeler HEC Pharm USA Inc.
Application ANDA213594
Marketing category ANDA
Marketing start 2026-03-25
Substance OSELTAMIVIR PHOSPHATE
Active strength 6 mg/mL
Pharmacologic classes Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213594-001 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213594-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213594-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-01-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Oseltamivir Phosphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OSELTAMIVIR PHOSPHATE 6 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4A3O49NGEZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1115698 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72303-0851-1 Oseltamivir Phosphate 1 in 1 CARTON SUSPENSION 1 1 72303-0851-1 Oseltamivir Phosphate 60 mL in 1 BOTTLE, PLASTIC SUSPENSION 60 1
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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72303-0851-1 72303085101 1 BOTTLE, PLASTIC in 1 CARTON (72303-0851-1) / 60 mL in 1 BOTTLE, PLASTIC 2026-03-25 No No Current