Oseltamivir phosphate

Product NDC: 68071-3960
11-digit product format: 680713960
Labeler code: 68071
Product ID: 68071-3960_497adf87-f393-e52c-e063-6394a90a4a50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oseltamivir phosphate
Dosage form: FOR SUSPENSION
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA212784
Marketing category: ANDA
Marketing start: 2020-05-28
Substance: OSELTAMIVIR PHOSPHATE
Active strength: 6 mg/mL
Pharmacologic classes: Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212784-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB		2020-05-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212784-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212784-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2020-05-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212784-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212784-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212784-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212784-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212784-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212784-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212784-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212784-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212784-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212784-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212784-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212784-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212784-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212784-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212784-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212784-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212784-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212784-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212784-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212784-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212784-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212784-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212784-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212784-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212784-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212784-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212784-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212784-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212784-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212784-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212784-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212784-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212784-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212784-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212784-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212784-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212784-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oseltamivir phosphate
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115698	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
497adf7b-9bdc-314e-e063-6394a90a63be	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3960-6	Oseltamivir phosphate	1 in 1 CARTON	FOR SUSPENSION	1		1
68071-3960-6	Oseltamivir phosphate	1 in 1 POUCH	FOR SUSPENSION	1		1

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	NuCare Pharmaceuticals, Inc.	497adf7b-9bdc-314e-e063-6394a90a63be	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212784 application number: ANDA212784 ndc (product): 68071-3960
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	16fcbcb4-609c-4d4e-a134-013823207dc7	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212784 application number: ANDA212784
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Ajanta Pharma USA Inc.	c6f78d2d-6452-4af3-83c6-b044d1604bdc	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212784 application number: ANDA212784

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	497adf7b-9bdc-314e-e063-6394a90a63be	1
1115698	oseltamivir 6 MG/ML Oral Suspension	SCD	497adf7b-9bdc-314e-e063-6394a90a63be	1
1115698	oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral Suspension	SY	497adf7b-9bdc-314e-e063-6394a90a63be	1
1115698	oseltamivir phosphate 6 MG per 1 ML Oral Suspension	SY	497adf7b-9bdc-314e-e063-6394a90a63be	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3960-6	68071396006	1 POUCH in 1 CARTON (68071-3960-6) / 1 BOTTLE in 1 POUCH / 60 mL in 1 BOTTLE	1 pouch	2026-01-28	No	No	Current