Home NDC 0004-0801 Tamiflu
Product NDC 0004-0801
11-digit product format 000040801
Labeler code 0004
Product ID 0004-0801_ce6467c3-e42d-4c77-8918-1bbcec3f6e41
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oseltamivir phosphate
Dosage form CAPSULE
Route ORAL
Labeler Genentech, Inc.
Application NDA021087
Marketing category NDA
Marketing start 1999-10-27
Marketing end 0000-00-00
Substance OSELTAMIVIR PHOSPHATE
Active strength 45 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0004-0801-85 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0004-0801-85 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021087-001 TAMIFLU OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 N021087-002 TAMIFLU OSELTAMIVIR PHOSPHATE EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2007-07-02 N021087-003 TAMIFLU OSELTAMIVIR PHOSPHATE EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2007-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021087-001 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 4 · 126 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 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021087-002 TAMIFLU EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2007-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021087-003 TAMIFLU EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2007-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL RLD 2007-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL RLD 2007-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL RLD 2007-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL RLD 2007-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 118 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0004-0801-85 Tamiflu 10 in 1 BLISTER PACK CAPSULE 10 45 0004-0801-85 Tamiflu 1 in 1 CARTON CAPSULE 1 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 oseltamivir phosphate ACTIVE INGREDIENT 4A3O49NGEZ TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 Oseltamivir ACTIVE MOIETY 20O93L6F9H TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0004-0801 TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION [GENENTECH, INC.] 44 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 Units Marketing start Marketing end Sample Exclude flag Status 0004-0801-85 00004080185 1 BLISTER PACK in 1 CARTON (0004-0801-85) > 10 CAPSULE in 1 BLISTER PACK 1 blister pack 1999-10-27 0000-00-00 No No Current