oseltamivir phosphate

Product NDC: 70436-225
11-digit product format: 704360225
Labeler code: 70436
Product ID: 70436-225_32f5c180-8169-55c5-e063-6294a90a3f20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oseltamivir phosphate
Dosage form: CAPSULE
Route: ORAL
Labeler: Slate Run Pharmaceuticals, LLC
Application: ANDA218009
Marketing category: ANDA
Marketing start: 2024-01-01
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

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	Approval date
A218009-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24
A218009-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2025-10-02
A218009-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2025-10-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218009-001	AB
A218009-002	AB
A218009-003	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.

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	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218009-002	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2025-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218009-003	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2025-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218009-002	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2025-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218009-003	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2025-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218009-001	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-11-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218009-002	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2025-10-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218009-003	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2025-10-02	`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	A218009-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218009-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218009-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218009-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218009-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218009-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218009-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218009-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218009-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218009-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218009-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218009-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218009-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218009-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218009-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218009-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218009-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218009-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218009-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A218009-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A218009-001	AB	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218009-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218009-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218009-003	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: oseltamivir phosphate
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 · 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
613c8c4d-e647-4a4b-ac9b-c39aaa781ace	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
70436-225-47	oseltamivir phosphate	10 in 1 BLISTER PACK	CAPSULE	10		3
70436-225-47	oseltamivir phosphate	1 in 1 CARTON	CAPSULE	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70436-225	OSELTAMIVIR PHOSPHATE CAPSULE [SLATE RUN PHARMACEUTICALS, LLC]	3	Current NDC, 2 package rows	20250418_613c8c4d-e647-4a4b-ac9b-c39aaa781ace.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Zhejiang Poly Pharm. Co., Ltd.	339778ee-0b6f-6d81-e063-6394a90a2d32	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218009 application number: ANDA218009
oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Slate Run Pharmaceuticals, LLC	613c8c4d-e647-4a4b-ac9b-c39aaa781ace	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218009 application number: ANDA218009 ndc (product): 70436-225

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
312122	oseltamivir phosphate 75 MG Oral Capsule	PSN	613c8c4d-e647-4a4b-ac9b-c39aaa781ace	3
312122	oseltamivir 75 MG Oral Capsule	SCD	613c8c4d-e647-4a4b-ac9b-c39aaa781ace	3
312122	oseltamivir (as oseltamivir phosphate) 75 MG Oral Capsule	SY	613c8c4d-e647-4a4b-ac9b-c39aaa781ace	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70436-225-47	70436022547	1 BLISTER PACK in 1 CARTON (70436-225-47) / 10 CAPSULE in 1 BLISTER PACK	1 blister pack	2024-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
oseltamivir phosphate	Slate Run Pharmaceuticals, LLC \| Zhejiang Poly Pharm. Co., Ltd \| Sinopep-Allsino Biopharmaceutical Co., Ltd.	2025-04-17	HUMAN PRESCRIPTION DRUG LABEL	3