Oseltamivir Phosphate

Product NDC: 50090-8015
Requested package NDC: 50090-8015-0
11-digit product format: 500908015
Labeler code: 50090
Product ID: 50090-8015_f8a0d121-0254-40be-ae76-c00159d94e75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oseltamivir phosphate
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA202595
Marketing category: ANDA
Marketing start: 2016-12-12
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 43.

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
A202595-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03
A202595-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03
A202595-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202595-001	AB
A202595-002	AB
A202595-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202595-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202595-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202595-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202595-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202595-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202595-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202595-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202595-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202595-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202595-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202595-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202595-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202595-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202595-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202595-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202595-001	AB	1	`301d65b070ca…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312122	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
e1bec65b-4292-4110-a840-aa48053b5448	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	e1bec65b-4292-4110-a840-aa48053b5448	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202595 application number: ANDA202595 ndc (package): 50090-8015-0 ndc (product): 50090-8015 ndc11 (package): 50090801500
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Alvogen Inc.	809f859e-0852-80d3-1a67-da87ed399c15	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202595 application number: ANDA202595

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-8015-0	50090801500	1 BLISTER PACK in 1 CARTON (50090-8015-0) / 10 CAPSULE in 1 BLISTER PACK	1 blister pack	2026-07-15	No	No	Current