Home NDC 68788-7600 Oseltamivir Phosphate
Product NDC 68788-7600
11-digit product format 687887600
Labeler code 68788
Product ID 68788-7600_c0622a5a-99ef-40df-9e02-1b1321d97f98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oseltamivir Phosphate
Dosage form FOR SUSPENSION
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA209113
Marketing category ANDA
Marketing start 2020-02-13
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 A209113-001 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209113-001 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.
Product history page 1 of 2 · 42 observed 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 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209113-001 OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB 2017-09-14 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 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 68788-7600-6 Oseltamivir Phosphate 1 in 1 CARTON FOR SUSPENSION 1 6 68788-7600-6 Oseltamivir Phosphate 60 mL in 1 BOTTLE FOR SUSPENSION 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7600 OSELTAMIVIR PHOSPHATE FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240726_b1abef84-d074-4872-9193-48a52cbabbd6.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 · 3 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 68788-7600-6 68788760006 1 BOTTLE in 1 CARTON (68788-7600-6) / 60 mL in 1 BOTTLE 1 bottle 2020-02-13 0000-00-00 No No Current