Home NDC 69315-174 OSELTAMIVIR PHOSPHATE
Product NDC 69315-174
11-digit product format 693150174
Labeler code 69315
Product ID 69315-174_473d55b2-bec6-4f76-b5a2-275431b2eb09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OSELTAMIVIR PHOSPHATE
Dosage form SUSPENSION
Route ORAL
Labeler Leading Pharma, LLC
Application ANDA214949
Marketing category ANDA
Marketing start 2022-06-01
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 42 .
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 A214949-001 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28
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 2026-08-18 06:07:40 2026-07 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-02-28 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-02-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2022-02-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214949-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL 2022-02-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base OSELTAMIVIR PHOSPHATE
Listing expiration 2026-12-31 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 69315-174-60 OSELTAMIVIR PHOSPHATE 60 mL in 1 BOTTLE SUSPENSION 60 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69315-174 OSELTAMIVIR PHOSPHATE SUSPENSION [LEADING PHARMA, LLC] 8 Current NDC, Legacy NDC, 1 package rows 20241009_ef093e4d-5b1a-463f-a1a3-b795a4387a81.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69315-174-60 69315017460 60 mL in 1 BOTTLE (69315-174-60) 60 ml 2022-06-01 0000-00-00 No No Current