Oseltamivir Phosphate

Product NDC: 85766-146
Requested package NDC: 85766-146-01
11-digit product format: 857660146
Labeler code: 85766
Product ID: 85766-146_4a9039c3-f834-55a8-e063-6394a90a99c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oseltamivir Phosphate
Dosage form: CAPSULE
Route: ORAL
Labeler: Sportpharm LLC
Application: ANDA209421
Marketing category: ANDA
Marketing start: 2018-10-05
Substance: OSELTAMIVIR PHOSPHATE
Active strength: 75 mg/1
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 44.

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	Approval date
A209421-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08
A209421-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08
A209421-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209421-001	AB
A209421-002	AB
A209421-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A209421-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209421-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209421-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209421-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209421-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209421-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209421-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209421-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209421-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209421-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209421-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209421-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209421-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209421-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209421-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209421-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209421-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209421-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209421-001	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312122	Internal RxNorm lookup
728109	Internal RxNorm lookup
728113	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
92726a00-4237-49fd-9e29-5d4f5f999874	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	SPL version
85766-146-01	Oseltamivir Phosphate	100 in 1 BOTTLE	CAPSULE	100	1
85766-146-05	Oseltamivir Phosphate	500 in 1 BOTTLE	CAPSULE	500	1
85766-146-10	Oseltamivir Phosphate	10 in 1 BLISTER PACK	CAPSULE	10	1
85766-146-30	Oseltamivir Phosphate	30 in 1 BOTTLE	CAPSULE	30	1
85766-146-60	Oseltamivir Phosphate	60 in 1 BOTTLE	CAPSULE	60	1
85766-146-90	Oseltamivir Phosphate	90 in 1 BOTTLE	CAPSULE	90	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Strides Pharma Science Limited	f26154bd-374c-44a8-983a-b2724a591653	2026-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	89a3539b-a067-4073-b7a0-d04e7f130396	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Sportpharm LLC	92726a00-4237-49fd-9e29-5d4f5f999874	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421 ndc (package): 85766-146-01 ndc (product): 85766-146 ndc11 (package): 85766014601
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	91eadf0b-5f04-4f5d-b095-02c5736a3647	2023-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Asclemed USA, Inc.	78f85d27-9935-4775-b8d7-275e11429b76	2023-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Proficient Rx LP	de553d49-38c3-4fad-8582-d4d27c3c26b1	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421

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	92726a00-4237-49fd-9e29-5d4f5f999874	1
728113	oseltamivir phosphate 45 MG Oral Capsule	PSN	92726a00-4237-49fd-9e29-5d4f5f999874	1
312122	oseltamivir phosphate 75 MG Oral Capsule	PSN	92726a00-4237-49fd-9e29-5d4f5f999874	1
728109	oseltamivir 30 MG Oral Capsule	SCD	92726a00-4237-49fd-9e29-5d4f5f999874	1
728113	oseltamivir 45 MG Oral Capsule	SCD	92726a00-4237-49fd-9e29-5d4f5f999874	1
312122	oseltamivir 75 MG Oral Capsule	SCD	92726a00-4237-49fd-9e29-5d4f5f999874	1
728109	oseltamivir (as oseltamivir phosphate) 30 MG Oral Capsule	SY	92726a00-4237-49fd-9e29-5d4f5f999874	1
728113	oseltamivir (as oseltamivir phosphate) 45 MG Oral Capsule	SY	92726a00-4237-49fd-9e29-5d4f5f999874	1
312122	oseltamivir (as oseltamivir phosphate) 75 MG Oral Capsule	SY	92726a00-4237-49fd-9e29-5d4f5f999874	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85766-146-01	85766014601	100 CAPSULE in 1 BOTTLE (85766-146-01)	100 capsule	2026-02-11	No	No	Current