Oseltamivir Phosphate

Product NDC: 76420-924
Requested package NDC: 76420-924-60
11-digit product format: 764200924
Labeler code: 76420
Product ID: 76420-924_2f2d697b-22f5-ccfa-e063-6394a90a7fde
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oseltamivir Phosphate
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA208347
Marketing category: ANDA
Marketing start: 2018-02-21
Substance: OSELTAMIVIR PHOSPHATE
Active strength: 6 mg/mL
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 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
A208347-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB		2018-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208347-001	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	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`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	A208347-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208347-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208347-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208347-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208347-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208347-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208347-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208347-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208347-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208347-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208347-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208347-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208347-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208347-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208347-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208347-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208347-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208347-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208347-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208347-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208347-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208347-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208347-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208347-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208347-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208347-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208347-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208347-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208347-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208347-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208347-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208347-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208347-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208347-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208347-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208347-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208347-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208347-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208347-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208347-001	AB	1	`f41ea6bd6efb…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OSELTAMIVIR PHOSPHATE	6 mg/mL

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
1115698	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
d9902b17-389b-45d4-b02f-67e35b0a5f3e	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
76420-924-60	Oseltamivir Phosphate	60 mL in 1 BOTTLE, GLASS	POWDER, FOR SUSPENSION	60		1
76420-924-60	Oseltamivir Phosphate	1 in 1 CARTON	POWDER, FOR SUSPENSION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-924	OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [ASCLEMED USA, INC.]	1	Current NDC, 2 package rows	20250305_d9902b17-389b-45d4-b02f-67e35b0a5f3e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Lupin Pharmaceuticals, Inc.	b428e1f2-0082-4d9f-908e-e3633ea0457b	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208347 application number: ANDA208347
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Asclemed USA, Inc.	d9902b17-389b-45d4-b02f-67e35b0a5f3e	2025-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208347 application number: ANDA208347 ndc (package): 76420-924-60 ndc (product): 76420-924 ndc11 (package): 76420092460
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	5194bb90-0876-48c4-a967-c862fbccd110	2023-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208347 application number: ANDA208347
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Proficient Rx LP	c754c2f7-7109-4498-aeee-c8ee088dfa98	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208347 application number: ANDA208347

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
1115698	oseltamivir phosphate 6 MG in 1 mL Oral Suspension	PSN	d9902b17-389b-45d4-b02f-67e35b0a5f3e	1
1115698	oseltamivir 6 MG/ML Oral Suspension	SCD	d9902b17-389b-45d4-b02f-67e35b0a5f3e	1
1115698	oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral Suspension	SY	d9902b17-389b-45d4-b02f-67e35b0a5f3e	1
1115698	oseltamivir phosphate 6 MG per 1 ML Oral Suspension	SY	d9902b17-389b-45d4-b02f-67e35b0a5f3e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
76420-924-60	76420092460	1 BOTTLE, GLASS in 1 CARTON (76420-924-60) / 60 mL in 1 BOTTLE, GLASS	2025-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oseltamivir Phosphate	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-27	HUMAN PRESCRIPTION DRUG LABEL	1