OSELTAMIVIR PHOSPHATE

Product NDC: 50090-3345
11-digit product format: 500903345
Labeler code: 50090
Product ID: 50090-3345_03b36352-e728-441b-9ee8-cb8fd35f921e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oseltamivir Phosphate
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA208823
Marketing category: ANDA
Marketing start: 2017-11-01
Marketing end: 0000-00-00
Substance: OSELTAMIVIR PHOSPHATE
Active strength: 6 mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-3345		D	Discontinued by firm		2026-10-05
excluded package	package	50090-3345	50090-3345-0	D	Discontinued by firm		2026-10-05

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 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3345-0	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3345-0	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-3345-0	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-3345-0	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-3345-0	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50090-3345-0	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50090-3345-0	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50090-3345-0	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50090-3345-0	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	50090-3345-0	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	50090-3345-0	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208823-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB		2017-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208823-001	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.

Product history page 1 of 2 · 43 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	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208823-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2017-10-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A208823-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208823-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208823-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208823-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208823-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208823-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208823-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208823-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208823-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208823-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208823-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208823-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208823-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208823-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208823-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208823-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208823-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208823-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208823-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208823-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208823-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208823-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208823-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208823-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208823-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208823-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208823-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208823-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208823-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208823-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208823-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208823-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208823-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208823-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208823-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208823-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208823-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208823-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208823-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208823-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3345-0	2024-07-02	C162847	48780-1	9d75b9d0-0bb0-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION. OSELTAMIVIR PHOSPHATE for oral suspension Initial U.S. Approval: 1999
50090-3345-0	2020-01-31	C162847	48780-1	9d75b9d0-0bb0-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION. OSELTAMIVIR PHOSPHATE for oral suspension Initial U.S. Approval: 1999

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3345-0	ML - Milliliter	50090-3345	c45e062d-587e-4d41-99ec-063116d33f03	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3345	OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]	9	Legacy NDC	20240704_a69727df-11bc-41f2-9420-900a3e215a3f.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 for Oral Suspension	OSELTAMIVIR PHOSPHATE	Alvogen Inc.	82df3237-636b-7bf9-3ba0-2b476e74bf4c	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208823 application number: ANDA208823
Oseltamivir Phosphate for Oral Suspension	OSELTAMIVIR PHOSPHATE	NuCare Pharmaceuticals,Inc.	27745acb-69a3-a1af-e063-6394a90ab10f	2024-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208823 application number: ANDA208823