Tamiflu

Product NDC
0004-0800
11-digit product format
000040800
Labeler code
0004
Product ID
0004-0800_94a312ac-c47a-4437-8dd3-6bcd7e08e42c
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
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0004-08000004-0800-08DDiscontinued by firm2026-08-03

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 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0004-0800-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0004-0800-85ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0004-0800-07ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0004-0800-08367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0004-0800-85367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0004-0800-07367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021087-001TAMIFLUOSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-27
N021087-002TAMIFLUOSELTAMIVIR PHOSPHATEEQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2007-07-02
N021087-003TAMIFLUOSELTAMIVIR PHOSPHATEEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2007-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021087-001AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALRLD2007-07-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALRLD2007-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALRLD2007-07-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALRLD2007-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALABRLD2007-07-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALABRLD2007-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALABRLD2007-07-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALABRLD2007-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALABRLD2007-07-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALABRLD2007-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALABRLD2007-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALABRLD2007-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALABRLD2007-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALABRLD2007-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALABRLD2007-07-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALABRLD2007-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALABRLD2007-07-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALABRLD2007-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALABRLD2007-07-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALABRLD2007-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALABRLD2007-07-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALABRLD2007-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALABRLD2007-07-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALABRLD2007-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021087-002TAMIFLUEQ 45MG BASECAPSULE / ORALABRLD2007-07-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021087-003TAMIFLUEQ 30MG BASECAPSULE / ORALABRLD2007-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021087-001TAMIFLUEQ 75MG BASECAPSULE / ORALABRLD, RS1999-10-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021087-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021087-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021087-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021087-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021087-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021087-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021087-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021087-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021087-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021087-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021087-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021087-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021087-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021087-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021087-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021087-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021087-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021087-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021087-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021087-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021087-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021087-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021087-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021087-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021087-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021087-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021087-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021087-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021087-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021087-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021087-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021087-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021087-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021087-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021087-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021087-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021087-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021087-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021087-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021087-002AB15c6f7cd8ea54…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021087-001M-2512022-08-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021087-002M-2512022-08-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021087-003M-2512022-08-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021087-001M-2512022-08-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021087-002M-2512022-08-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021087-003M-2512022-08-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021087-001M-2512022-08-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021087-002M-2512022-08-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021087-003M-2512022-08-024b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N021087-001M-2512022-08-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021087-002M-2512022-08-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021087-003M-2512022-08-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021087-001M-2512022-08-02782e0a99824c…
2021-12-28 21:50 UTC2021-12N021087-002M-2512022-08-02782e0a99824c…
2021-12-28 21:50 UTC2021-12N021087-003M-2512022-08-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021087-001M-2512022-08-0287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021087-002M-2512022-08-0287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021087-003M-2512022-08-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N021087-001M-2512022-08-025aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021087-002M-2512022-08-025aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021087-003M-2512022-08-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021087-001M-2512022-08-028869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021087-002M-2512022-08-028869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021087-003M-2512022-08-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021087-001M-2512022-08-02c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021087-002M-2512022-08-02c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021087-003M-2512022-08-02c0c555d07b60…
2023-01-26 05:58 UTC2023-01N021087-001M-2512022-08-023bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021087-002M-2512022-08-023bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021087-003M-2512022-08-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021087-001M-2512022-08-023a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021087-002M-2512022-08-023a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021087-003M-2512022-08-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021087-001M-2512022-08-02f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021087-002M-2512022-08-02f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021087-003M-2512022-08-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021087-001M-2512022-08-02e64feba35796…
2022-09-29 23:25 UTC2022-09N021087-002M-2512022-08-02e64feba35796…
2022-09-29 23:25 UTC2022-09N021087-003M-2512022-08-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021087-001M-2512022-08-02cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Tamiflu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4A3O49NGEZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
261315Internal RxNorm lookup
312122Internal RxNorm lookup
728109Internal RxNorm lookup
728111Internal RxNorm lookup
728113Internal RxNorm lookup
728115Internal RxNorm lookup
1115698Internal RxNorm lookup
1115700Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee3c9555-60f2-4f82-a760-11983c86e97bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0004-0800-072024-12-11These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU ® (oseltamivir phosphate) capsules, for oral use TAMIFLU ® (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999
0004-0800-082024-12-11These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU ® (oseltamivir phosphate) capsules, for oral use TAMIFLU ® (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999
0004-0800-852024-12-11These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU ® (oseltamivir phosphate) capsules, for oral use TAMIFLU ® (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999
0004-0800-072024-07-30These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU ® (oseltamivir phosphate) capsules, for oral use TAMIFLU ® (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999
0004-0800-082024-07-30These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU ® (oseltamivir phosphate) capsules, for oral use TAMIFLU ® (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999
0004-0800-852024-07-30These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU ® (oseltamivir phosphate) capsules, for oral use TAMIFLU ® (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0004-0800-07Tamiflu1 in 1 CARTONCAPSULE145
0004-0800-07Tamiflu10 in 1 BOTTLE, PLASTICCAPSULE1045
0004-0800-08Tamiflu10 in 1 BOTTLE, PLASTICCAPSULE1045
0004-0800-08Tamiflu1 in 1 CARTONCAPSULE145
0004-0800-85Tamiflu10 in 1 BLISTER PACKCAPSULE1045
0004-0800-85Tamiflu1 in 1 CARTONCAPSULE145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0004-0800-07EA - Each0004-0800c89f7115-1e60-424f-b029-9d0ca2b1a4a312023-05-05
0004-0800-08EA - Each0004-0800424956a3-246c-4bd6-a2c3-606de30bf0f712023-03-13
0004-0800-85EA - Each0004-08004626137c-bb75-4d67-a92d-e529741cfdad12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oseltamivir PhosphateACTIVE INGREDIENT4A3O49NGEZTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
Oseltamivir CarboxylateACTIVE MOIETYK6106LV5Q8TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
ferric oxide redINACTIVE INGREDIENT1K09F3G675TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
gelatinINACTIVE INGREDIENT2G86QN327LTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
monosodium citrateINACTIVE INGREDIENT68538UP9SETAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
povidone k30INACTIVE INGREDIENTU725QWY32XTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
sodium stearyl fumarateINACTIVE INGREDIENT7CV7WJK4UITAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
sorbitolINACTIVE INGREDIENT506T60A25RTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
starch, cornINACTIVE INGREDIENTO8232NY3SJTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
talcINACTIVE INGREDIENT7SEV7J4R1UTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
xanthan gumINACTIVE INGREDIENTTTV12P4NEETAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [GENENTECH, INC.]30
oseltamivir phosphateACTIVE INGREDIENT4A3O49NGEZTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
OseltamivirACTIVE MOIETY20O93L6F9HTAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0004-0800TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION [GENENTECH, INC.]44Current NDC, Legacy NDC, 6 package rows20241213_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TamifluOSELTAMIVIR PHOSPHATEGenentech, Inc.ee3c9555-60f2-4f82-a760-11983c86e97b2025-12-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 021087
application number: NDA021087
ndc (product): 0004-0800

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
728113oseltamivir phosphate 45 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSNee3c9555-60f2-4f82-a760-11983c86e97b45
312122oseltamivir phosphate 75 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
728111Tamiflu 30 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
728115Tamiflu 45 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
1115700Tamiflu 6 MG in 1 mL Oral SuspensionPSNee3c9555-60f2-4f82-a760-11983c86e97b45
261315Tamiflu 75 MG Oral CapsulePSNee3c9555-60f2-4f82-a760-11983c86e97b45
728111oseltamivir 30 MG Oral Capsule [Tamiflu]SBDee3c9555-60f2-4f82-a760-11983c86e97b45
728115oseltamivir 45 MG Oral Capsule [Tamiflu]SBDee3c9555-60f2-4f82-a760-11983c86e97b45
1115700oseltamivir 6 MG/ML Oral Suspension [Tamiflu]SBDee3c9555-60f2-4f82-a760-11983c86e97b45
261315oseltamivir 75 MG Oral Capsule [Tamiflu]SBDee3c9555-60f2-4f82-a760-11983c86e97b45
728109oseltamivir 30 MG Oral CapsuleSCDee3c9555-60f2-4f82-a760-11983c86e97b45
728113oseltamivir 45 MG Oral CapsuleSCDee3c9555-60f2-4f82-a760-11983c86e97b45
1115698oseltamivir 6 MG/ML Oral SuspensionSCDee3c9555-60f2-4f82-a760-11983c86e97b45
312122oseltamivir 75 MG Oral CapsuleSCDee3c9555-60f2-4f82-a760-11983c86e97b45
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSYee3c9555-60f2-4f82-a760-11983c86e97b45
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSYee3c9555-60f2-4f82-a760-11983c86e97b45
728111Tamiflu 30 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45
728115Tamiflu 45 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45
1115700Tamiflu 6 MG per 1 ML Oral SuspensionSYee3c9555-60f2-4f82-a760-11983c86e97b45
1115700Tamiflu 6 MG/ML Oral SuspensionSYee3c9555-60f2-4f82-a760-11983c86e97b45
261315Tamiflu 75 MG Oral CapsuleSYee3c9555-60f2-4f82-a760-11983c86e97b45
728113oseltamivir phosphate 45 MG Oral CapsulePSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
312122oseltamivir phosphate 75 MG Oral CapsulePSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
728115Tamiflu 45 MG Oral CapsulePSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115700Tamiflu 6 MG in 1 mL Oral SuspensionPSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
261315Tamiflu 75 MG Oral CapsulePSN1948cafd-b5b3-4212-9d5d-8c293b1baad52
728115oseltamivir 45 MG Oral Capsule [Tamiflu]SBD1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115700oseltamivir 6 MG/ML Oral Suspension [Tamiflu]SBD1948cafd-b5b3-4212-9d5d-8c293b1baad52
261315oseltamivir 75 MG Oral Capsule [Tamiflu]SBD1948cafd-b5b3-4212-9d5d-8c293b1baad52
728113oseltamivir 45 MG Oral CapsuleSCD1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115698oseltamivir 6 MG/ML Oral SuspensionSCD1948cafd-b5b3-4212-9d5d-8c293b1baad52
312122oseltamivir 75 MG Oral CapsuleSCD1948cafd-b5b3-4212-9d5d-8c293b1baad52
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
728115Tamiflu 45 MG Oral CapsuleSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115700Tamiflu 6 MG per 1 ML Oral SuspensionSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
1115700Tamiflu 6 MG/ML Oral SuspensionSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
261315Tamiflu 75 MG Oral CapsuleSY1948cafd-b5b3-4212-9d5d-8c293b1baad52
312122oseltamivir phosphate 75 MG Oral CapsulePSN1b28c7c8-08c7-5ee9-e063-6394a90a72101
261315Tamiflu 75 MG Oral CapsulePSN1b28c7c8-08c7-5ee9-e063-6394a90a72101
261315oseltamivir 75 MG Oral Capsule [Tamiflu]SBD1b28c7c8-08c7-5ee9-e063-6394a90a72101
312122oseltamivir 75 MG Oral CapsuleSCD1b28c7c8-08c7-5ee9-e063-6394a90a72101
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1b28c7c8-08c7-5ee9-e063-6394a90a72101
261315Tamiflu 75 MG Oral CapsuleSY1b28c7c8-08c7-5ee9-e063-6394a90a72101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0004-0800-07000040800071 BOTTLE, PLASTIC in 1 CARTON (0004-0800-07) / 10 CAPSULE in 1 BOTTLE, PLASTIC2005-06-170000-00-00NoNoCurrent
0004-0800-08000040800081 BOTTLE, PLASTIC in 1 CARTON (0004-0800-08) / 10 CAPSULE in 1 BOTTLE, PLASTIC2005-06-172026-05-31NoNoCurrent
0004-0800-85000040800851 BLISTER PACK in 1 CARTON (0004-0800-85) / 10 CAPSULE in 1 BLISTER PACK1 blister pack1999-10-270000-00-00NoNoCurrent