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 1.

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 · 41 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	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…`
2022-09-29 23:25 UTC	2022-09	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208347-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2018-02-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	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…`
2022-09-29 23:25 UTC	2022-09	A208347-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208347-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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