Oseltamivir Phosphate

Product NDC: 68071-4743
Requested package NDC: 68071-4743-6
11-digit product format: 680714743
Labeler code: 68071
Product ID: 68071-4743_bb8d80e8-ccf7-25fc-e053-2995a90a0b89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oseltamivir Phosphate
Dosage form: FOR SUSPENSION
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA209113
Marketing category: ANDA
Marketing start: 2017-09-14
Marketing end: 0000-00-00
Substance: OSELTAMIVIR PHOSPHATE
Active strength: 6 mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-4743	68071-4743-6	I	Inactivated by FDA		2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209113-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209113-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209113-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209113-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209113-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209113-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209113-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209113-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209113-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209113-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209113-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209113-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209113-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209113-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209113-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209113-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209113-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209113-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209113-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209113-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209113-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209113-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209113-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209113-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209113-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209113-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209113-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209113-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209113-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209113-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209113-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209113-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209113-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209113-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209113-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209113-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209113-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209113-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209113-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209113-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6022fcc-885e-41f7-971c-fe19ade5d9ba	Product name	9	20190926

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-4743-6	2023-01-30	C162847	48780-1	ba0f9c33-52ac-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION. OSELTAMIVIR PHOSPHATE for oral suspension Initial U.S. Approval: 1999
68071-4743-6	2021-02-17	C162847	48780-1	ba0f9c33-52ac-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION. OSELTAMIVIR PHOSPHATE for oral suspension Initial U.S. Approval: 1999
68071-4743-6	2021-01-29	C162847	48780-1	ba0f9c33-52ac-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION. OSELTAMIVIR PHOSPHATE for oral suspension Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4743-6	Oseltamivir Phosphate	60 mL in 1 BOTTLE	FOR SUSPENSION	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4743	OSELTAMIVIR PHOSPHATE FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]	3	Legacy NDC, 1 package rows	20210218_80b25513-4ee7-7f07-e053-2991aa0ab106.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	b1abef84-d074-4872-9193-48a52cbabbd6	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209113 application number: ANDA209113
Oseltamivir Phosphate	OSELTAMIVIR ACID	Zydus Lifesciences Limited	7c0923ad-80b0-4134-b44a-754ea599f356	2024-12-09		Exact identifier application applno (ANDA): 209113 application number: ANDA209113
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals USA Inc.	432d9e7b-9cb2-4b7d-9fb2-015449096757	2023-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209113 application number: ANDA209113

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
1115698	oseltamivir phosphate 6 MG in 1 mL Oral Suspension	PSN	80b25513-4ee7-7f07-e053-2991aa0ab106	3
1115698	oseltamivir 6 MG/ML Oral Suspension	SCD	80b25513-4ee7-7f07-e053-2991aa0ab106	3
1115698	oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral Suspension	SY	80b25513-4ee7-7f07-e053-2991aa0ab106	3
1115698	oseltamivir phosphate 6 MG per 1 ML Oral Suspension	SY	80b25513-4ee7-7f07-e053-2991aa0ab106	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4743-6	68071474306	60 mL in 1 BOTTLE (68071-4743-6)	60 ml	2019-01-30	0000-00-00	No	No	Current