Application 020781

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOFRAN ODT	ONDANSETRON	TABLET, ORALLY DISINTEGRATING;ORAL	4MG	Yes	No
002	ZOFRAN ODT	ONDANSETRON	TABLET, ORALLY DISINTEGRATING;ORAL	8MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020781-001	ZOFRAN ODT	ONDANSETRON	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27
N020781-002	ZOFRAN ODT	ONDANSETRON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020781-001	ZOFRAN ODT	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020781-002	ZOFRAN ODT	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020781-001	ZOFRAN ODT	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020781-002	ZOFRAN ODT	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020781-001	ZOFRAN ODT	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020781-002	ZOFRAN ODT	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020781-001	ZOFRAN ODT	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020781-002	ZOFRAN ODT	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1999-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020781-001	ZOFRAN ODT	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	1999-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020781-002	ZOFRAN ODT	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1999-01-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020781-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020781-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020781-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020781-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020781-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020781-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020781-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020781-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020781-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020781-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020781-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020781-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020781-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020781-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020781-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020781-002	AB	1	`ea99ee380514…`

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 5 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	NorthStar Rx LLC	281e4296-1d0e-4602-9912-2685ba1640f6	2025-07-17	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	ee668456-a214-4452-ab9d-ec00eaa41d79	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Aurobindo Pharma Limited	cab63f24-8728-4927-aba5-53e8d2e44cdb	2025-07-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	72f29916-0f95-102d-e053-2991aa0aa5cd	2025-06-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	ee1f115f-c8f8-4526-b827-c8e48aeb5050	2025-06-20	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92c758a3-e749-4a15-be4b-ee30b364b2b0	2025-06-12	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	40d9cc46-aced-4866-812b-7d82933596ae	2025-06-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Bryant Ranch Prepack	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	2025-06-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Advanced Rx Pharmacy of Tennessee, LLC	f1a0b9ee-c1d2-7818-e053-2995a90a3e96	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	ATLANTIC BIOLOGICALS CORP.	e5ab38a2-5921-4320-a313-e0080c078046	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals, Inc.	2eeb3c61-4ce9-d8ed-e063-6294a90a00d3	2025-02-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Asclemed USA, Inc.	e436e361-da0f-7d6d-e053-2995a90a10e4	2025-02-21	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	7b062fa9-e004-23d5-e053-2a91aa0a20cd	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	99ac0a5e-dd2a-4352-e053-2a95a90a68fd	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron ODT	ONDANSETRON	Advanced Rx of Tennessee, LLC	af836a30-5e51-5c97-e053-2995a90a15b9	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Advanced Rx Pharmacy of Tennessee, LLC	f1a0ea2c-0788-4e8a-e053-2a95a90a2f32	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Advanced Rx Pharmacy of Tennessee, LLC	f1a0cd50-aa4f-55bc-e053-2995a90a2d3a	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	e183c59c-2a7c-dba3-e053-2a95a90acf87	2024-12-30	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Advanced Rx of Tennessee, LLC	2a8603a9-5b6f-b921-e063-6394a90ae29c	2024-12-29	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Advanced Rx of Tennessee, LLC	2a863485-a0a8-db63-e063-6294a90ab605	2024-12-29	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0679	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0679	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0680	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0680	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82444	SUPPL	2025-06-04
82443	SUPPL	2025-06-03
69073	SUPPL	2021-10-22
69056	SUPPL	2021-10-21
67248	SUPPL	2021-04-29
67242	SUPPL	2021-04-29
54223	SUPPL	2018-05-17
49978	SUPPL	2017-10-06
49964	SUPPL	2017-10-06
45881	SUPPL	2016-11-10
45877	SUPPL	2016-11-10
45486	SUPPL	2016-09-30
25822	SUPPL	2014-09-23
13429	SUPPL	2014-09-22
3345	SUPPL	2013-12-13
35350	SUPPL	2013-12-11
44070	ORIG	2011-12-20
35349	SUPPL	2011-09-16
25821	SUPPL	2011-09-16
13428	SUPPL	2010-09-29
3344	SUPPL	2010-09-27
20949	SUPPL	2007-09-26
25820	SUPPL	2006-09-18
35348	SUPPL	2006-08-23
25819	SUPPL	2006-01-06
13427	SUPPL	2004-12-03
3343	SUPPL	2004-12-02
25818	SUPPL	2004-07-01
41698	ORIG	1999-01-27
25817	ORIG	1999-01-27
13426	ORIG	1999-01-27