Home NDC 0004-0822 Tamiflu
Product NDC 0004-0822
11-digit product format 000040822
Labeler code 0004
Product ID 0004-0822_94a312ac-c47a-4437-8dd3-6bcd7e08e42c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oseltamivir Phosphate
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Genentech, Inc.
Application NDA021246
Marketing category NDA
Marketing start 2011-03-21
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021246-001 TAMIFLU OSELTAMIVIR PHOSPHATE EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 N021246-002 TAMIFLU OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021246-002 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Tamiflu
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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 261315 Internal RxNorm lookup 312122 Internal RxNorm lookup 728109 Internal RxNorm lookup 728111 Internal RxNorm lookup 728113 Internal RxNorm lookup 728115 Internal RxNorm lookup 1115698 Internal RxNorm lookup 1115700 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 0004-0822-05 Tamiflu 1 in 1 CARTON POWDER, FOR SUSPENSION 1 45 0004-0822-05 Tamiflu 60 mL in 1 BOTTLE, GLASS POWDER, FOR SUSPENSION 60 45
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Oseltamivir Phosphate ACTIVE INGREDIENT 4A3O49NGEZ TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 Oseltamivir Carboxylate ACTIVE MOIETY K6106LV5Q8 TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 FD&C blue No. 2 INACTIVE INGREDIENT L06K8R7DQK TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 gelatin INACTIVE INGREDIENT 2G86QN327L TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 monosodium citrate INACTIVE INGREDIENT 68538UP9SE TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 povidone k30 INACTIVE INGREDIENT U725QWY32X TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 sodium stearyl fumarate INACTIVE INGREDIENT 7CV7WJK4UI TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 sorbitol INACTIVE INGREDIENT 506T60A25R TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 starch, corn INACTIVE INGREDIENT O8232NY3SJ TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 talc INACTIVE INGREDIENT 7SEV7J4R1U TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30 xanthan gum INACTIVE INGREDIENT TTV12P4NEE TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.] 30
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0004-0822 TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION [GENENTECH, INC.] 44 Current NDC, Legacy NDC, 2 package rows 20241213_ee3c9555-60f2-4f82-a760-11983c86e97b.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 Marketing start Marketing end Sample Exclude flag Status 0004-0822-05 00004082205 1 BOTTLE, GLASS in 1 CARTON (0004-0822-05) / 60 mL in 1 BOTTLE, GLASS 2011-03-21 0000-00-00 No No Current