Oseltamivir Phosphate

Product NDC: 48792-7901
Requested package NDC: 48792-7901-1
11-digit product format: 487927901
Labeler code: 48792
Product ID: 48792-7901_a0123c0b-3e47-5f7b-e053-2a95a90ab2ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oseltamivir phosphate
Dosage form: CAPSULE
Route: ORAL
Labeler: Sunshine Lake Pharma Co., Ltd.
Application: ANDA212739
Marketing category: ANDA
Marketing start: 2020-03-05
Marketing end: 0000-00-00
Substance: OSELTAMIVIR PHOSPHATE
Active strength: 75 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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	48792-7901	48792-7901-1	D	Discontinued by firm		2026-08-03

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 · 12 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…`

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
A212739-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04
A212739-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04
A212739-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212739-001	AB
A212739-002	AB
A212739-003	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 3 · 111 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
2026-02-19 14:30 UTC	2026-02	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212739-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2020-03-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212739-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212739-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2020-03-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212739-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212739-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212739-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212739-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212739-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212739-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212739-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212739-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212739-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212739-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212739-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212739-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212739-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212739-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212739-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212739-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212739-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212739-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212739-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212739-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212739-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212739-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212739-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212739-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212739-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212739-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212739-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212739-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212739-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212739-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212739-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212739-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212739-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212739-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212739-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212739-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212739-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212739-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212739-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212739-001	AB	1	`8072bd15b7f6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Redpharm Drug	2fd237e8-7ac9-f473-e063-6294a90aadfc	2025-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212739 application number: ANDA212739
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Redpharm Drug	2fd1d9f7-a4e0-7fda-e063-6294a90ad425	2025-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212739 application number: ANDA212739
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	7c885cfb-46a0-4e18-ab96-03031b70b9d4	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212739 application number: ANDA212739
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Lannett Company, Inc.	00e2e995-6296-b544-e063-6294a90a8345	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212739 application number: ANDA212739

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	Marketing end	Sample	Exclude flag	Status
48792-7901-1	48792790101	1 BLISTER PACK in 1 CARTON (48792-7901-1) > 10 CAPSULE in 1 BLISTER PACK	1 blister pack	2020-03-05	0000-00-00	No	No	Current