Tamiflu

Product NDC: 0004-0800
Requested package NDC: 0004-0800-85
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0004-0800	0004-0800-85	I	Inactivated by FDA		excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0004-0800	0004-0800-85	I	Inactivated by FDA		excluded / ndc_excluded.zip	`367a005e9d99…`	`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-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TAMIFLU	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2007-07-02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TAMIFLU	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2007-07-02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 · 123 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021087-002	TAMIFLU	EQ 45MG BASE	CAPSULE / ORAL	AB	RLD	2007-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021087-003	TAMIFLU	EQ 30MG BASE	CAPSULE / ORAL	AB	RLD	2007-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021087-001	TAMIFLU	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, RS	1999-10-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021087-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021087-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021087-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021087-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021087-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021087-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021087-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021087-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021087-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021087-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021087-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021087-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021087-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021087-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021087-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021087-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021087-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021087-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021087-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021087-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021087-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021087-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021087-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021087-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021087-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021087-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021087-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021087-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021087-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021087-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021087-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021087-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021087-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021087-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021087-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021087-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021087-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021087-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021087-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021087-002	AB	1	`5c6f7cd8ea54…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021087-001	M-251	2022-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021087-002	M-251	2022-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021087-003	M-251	2022-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021087-001	M-251	2022-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021087-002	M-251	2022-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021087-003	M-251	2022-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021087-001	M-251	2022-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021087-002	M-251	2022-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021087-003	M-251	2022-08-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021087-001	M-251	2022-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021087-002	M-251	2022-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021087-003	M-251	2022-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021087-001	M-251	2022-08-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021087-002	M-251	2022-08-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021087-003	M-251	2022-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021087-001	M-251	2022-08-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021087-002	M-251	2022-08-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021087-003	M-251	2022-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021087-001	M-251	2022-08-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021087-002	M-251	2022-08-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021087-003	M-251	2022-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021087-001	M-251	2022-08-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021087-002	M-251	2022-08-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021087-003	M-251	2022-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021087-001	M-251	2022-08-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021087-002	M-251	2022-08-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021087-003	M-251	2022-08-02	`c0c555d07b60…`
2023-01-26 05:58 UTC	2023-01	N021087-001	M-251	2022-08-02	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021087-002	M-251	2022-08-02	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021087-003	M-251	2022-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021087-001	M-251	2022-08-02	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021087-002	M-251	2022-08-02	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021087-003	M-251	2022-08-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021087-001	M-251	2022-08-02	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021087-002	M-251	2022-08-02	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021087-003	M-251	2022-08-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021087-001	M-251	2022-08-02	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021087-002	M-251	2022-08-02	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021087-003	M-251	2022-08-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021087-001	M-251	2022-08-02	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OSELTAMIVIR PHOSPHATE	75 mg/1

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ee3c9555-60f2-4f82-a760-11983c86e97b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
c6022fcc-885e-41f7-971c-fe19ade5d9ba	Product name	9	20190926
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0004-0800-07	2024-12-11	These 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
0004-0800-08	2024-12-11	These 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
0004-0800-85	2024-12-11	These 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
0004-0800-07	2024-07-30	These 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
0004-0800-08	2024-07-30	These 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
0004-0800-85	2024-07-30	These 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 NDC	Product	Description	Form	Quantity	SPL version
0004-0800-07	Tamiflu	1 in 1 CARTON	CAPSULE	1	45
0004-0800-07	Tamiflu	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	45
0004-0800-08	Tamiflu	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	45
0004-0800-08	Tamiflu	1 in 1 CARTON	CAPSULE	1	45
0004-0800-85	Tamiflu	10 in 1 BLISTER PACK	CAPSULE	10	45
0004-0800-85	Tamiflu	1 in 1 CARTON	CAPSULE	1	45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0004-0800-07	EA - Each	0004-0800	c89f7115-1e60-424f-b029-9d0ca2b1a4a3	1	2023-05-05
0004-0800-08	EA - Each	0004-0800	424956a3-246c-4bd6-a2c3-606de30bf0f7	1	2023-03-13
0004-0800-85	EA - Each	0004-0800	4626137c-bb75-4d67-a92d-e529741cfdad	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
0004-0800	TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION [GENENTECH, INC.]	44	Current NDC, Legacy NDC, 6 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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamiflu	OSELTAMIVIR PHOSPHATE	Genentech, Inc.	ee3c9555-60f2-4f82-a760-11983c86e97b	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021087 application number: NDA021087 ndc (package): 0004-0800-85 ndc (product): 0004-0800 ndc11 (package): 00004080085

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4A3O49NGEZ	OSELTAMIVIR PHOSPHATE	204255-11-8	OSELTAMIVIR PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
728109	oseltamivir phosphate 30 MG Oral Capsule	PSN	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728113	oseltamivir phosphate 45 MG Oral Capsule	PSN	ee3c9555-60f2-4f82-a760-11983c86e97b	45
1115698	oseltamivir phosphate 6 MG in 1 mL Oral Suspension	PSN	ee3c9555-60f2-4f82-a760-11983c86e97b	45
312122	oseltamivir phosphate 75 MG Oral Capsule	PSN	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728111	Tamiflu 30 MG Oral Capsule	PSN	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728115	Tamiflu 45 MG Oral Capsule	PSN	ee3c9555-60f2-4f82-a760-11983c86e97b	45
1115700	Tamiflu 6 MG in 1 mL Oral Suspension	PSN	ee3c9555-60f2-4f82-a760-11983c86e97b	45
261315	Tamiflu 75 MG Oral Capsule	PSN	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728111	oseltamivir 30 MG Oral Capsule [Tamiflu]	SBD	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728115	oseltamivir 45 MG Oral Capsule [Tamiflu]	SBD	ee3c9555-60f2-4f82-a760-11983c86e97b	45
1115700	oseltamivir 6 MG/ML Oral Suspension [Tamiflu]	SBD	ee3c9555-60f2-4f82-a760-11983c86e97b	45
261315	oseltamivir 75 MG Oral Capsule [Tamiflu]	SBD	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728109	oseltamivir 30 MG Oral Capsule	SCD	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728113	oseltamivir 45 MG Oral Capsule	SCD	ee3c9555-60f2-4f82-a760-11983c86e97b	45
1115698	oseltamivir 6 MG/ML Oral Suspension	SCD	ee3c9555-60f2-4f82-a760-11983c86e97b	45
312122	oseltamivir 75 MG Oral Capsule	SCD	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728109	oseltamivir (as oseltamivir phosphate) 30 MG Oral Capsule	SY	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728113	oseltamivir (as oseltamivir phosphate) 45 MG Oral Capsule	SY	ee3c9555-60f2-4f82-a760-11983c86e97b	45
1115698	oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral Suspension	SY	ee3c9555-60f2-4f82-a760-11983c86e97b	45
312122	oseltamivir (as oseltamivir phosphate) 75 MG Oral Capsule	SY	ee3c9555-60f2-4f82-a760-11983c86e97b	45
1115698	oseltamivir phosphate 6 MG per 1 ML Oral Suspension	SY	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728111	Tamiflu 30 MG Oral Capsule	SY	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728115	Tamiflu 45 MG Oral Capsule	SY	ee3c9555-60f2-4f82-a760-11983c86e97b	45
1115700	Tamiflu 6 MG per 1 ML Oral Suspension	SY	ee3c9555-60f2-4f82-a760-11983c86e97b	45
1115700	Tamiflu 6 MG/ML Oral Suspension	SY	ee3c9555-60f2-4f82-a760-11983c86e97b	45
261315	Tamiflu 75 MG Oral Capsule	SY	ee3c9555-60f2-4f82-a760-11983c86e97b	45
728113	oseltamivir phosphate 45 MG Oral Capsule	PSN	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
1115698	oseltamivir phosphate 6 MG in 1 mL Oral Suspension	PSN	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
312122	oseltamivir phosphate 75 MG Oral Capsule	PSN	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
728115	Tamiflu 45 MG Oral Capsule	PSN	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
1115700	Tamiflu 6 MG in 1 mL Oral Suspension	PSN	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
261315	Tamiflu 75 MG Oral Capsule	PSN	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
728115	oseltamivir 45 MG Oral Capsule [Tamiflu]	SBD	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
1115700	oseltamivir 6 MG/ML Oral Suspension [Tamiflu]	SBD	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
261315	oseltamivir 75 MG Oral Capsule [Tamiflu]	SBD	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
728113	oseltamivir 45 MG Oral Capsule	SCD	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
1115698	oseltamivir 6 MG/ML Oral Suspension	SCD	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
312122	oseltamivir 75 MG Oral Capsule	SCD	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
728113	oseltamivir (as oseltamivir phosphate) 45 MG Oral Capsule	SY	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
1115698	oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral Suspension	SY	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
312122	oseltamivir (as oseltamivir phosphate) 75 MG Oral Capsule	SY	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
1115698	oseltamivir phosphate 6 MG per 1 ML Oral Suspension	SY	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
728115	Tamiflu 45 MG Oral Capsule	SY	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
1115700	Tamiflu 6 MG per 1 ML Oral Suspension	SY	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
1115700	Tamiflu 6 MG/ML Oral Suspension	SY	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
261315	Tamiflu 75 MG Oral Capsule	SY	1948cafd-b5b3-4212-9d5d-8c293b1baad5	2
312122	oseltamivir phosphate 75 MG Oral Capsule	PSN	1b28c7c8-08c7-5ee9-e063-6394a90a7210	1
261315	Tamiflu 75 MG Oral Capsule	PSN	1b28c7c8-08c7-5ee9-e063-6394a90a7210	1
261315	oseltamivir 75 MG Oral Capsule [Tamiflu]	SBD	1b28c7c8-08c7-5ee9-e063-6394a90a7210	1
312122	oseltamivir 75 MG Oral Capsule	SCD	1b28c7c8-08c7-5ee9-e063-6394a90a7210	1
312122	oseltamivir (as oseltamivir phosphate) 75 MG Oral Capsule	SY	1b28c7c8-08c7-5ee9-e063-6394a90a7210	1
261315	Tamiflu 75 MG Oral Capsule	SY	1b28c7c8-08c7-5ee9-e063-6394a90a7210	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0004-0800-85	00004080085	1 BLISTER PACK in 1 CARTON (0004-0800-85) / 10 CAPSULE in 1 BLISTER PACK	1 blister pack	1999-10-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tamiflu	Genentech, Inc. \| Sharp Packaging Services, LLC \| F. Hoffmann-La Roche AG	2025-12-15	HUMAN PRESCRIPTION DRUG LABEL	45
Tamiflu	Redpharm Drug	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL	1
Tamiflu	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	12
Tamiflu	REMEDYREPACK INC.	2022-03-24	HUMAN PRESCRIPTION DRUG LABEL	6
Tamiflu	Physicians Total Care, Inc.	2011-12-22	HUMAN PRESCRIPTION DRUG LABEL	2