ondansetron

Product NDC: 68788-7705
Requested package NDC: 68788-7705-3
11-digit product format: 687887705
Labeler code: 68788
Product ID: 68788-7705_aa7e55f3-0032-49f5-b687-13176abfa934
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA077557
Marketing category: ANDA
Marketing start: 2020-05-01
Marketing end: 0000-00-00
Substance: ONDANSETRON
Active strength: 8 mg/1
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	68788-7705	68788-7705-3	D	Discontinued by firm		2026-08-11

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077557-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-08-02
A077557-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-08-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077557-001	AB
A077557-002	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 · 82 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	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A077557-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077557-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077557-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077557-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077557-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077557-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077557-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077557-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077557-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077557-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077557-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077557-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077557-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077557-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077557-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077557-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077557-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077557-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7705-1	EA - Each	68788-7705	b5e6a7e4-e0a4-462e-a4e5-e0063d481299	1	2020-08-06
68788-7705-3	EA - Each	68788-7705	1202eac2-35eb-40f4-83d0-08ead914f981	1	2020-08-06

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ondansetron	ONDANSETRON	Cardinal Health 107, LLC	26aff90c-49ea-46ac-bbf3-c188c2b061c9	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92c758a3-e749-4a15-be4b-ee30b364b2b0	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ONDANSETRON	ONDANSETRON	Bryant Ranch Prepack	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	b297c163-2052-cb22-e053-2995a90a8289	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	a1dd7420-dd81-2c8e-e053-2995a90ac8e6	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ONDANSETRON	ONDANSETRON	Proficient Rx LP	4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ONDANSETRON	ONDANSETRON	Proficient Rx LP	9913ed0c-aaad-45e1-b522-98ad170c2e8a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4AF302ESOS	ONDANSETRON	99614-02-5	ONDANSETRON

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7705-3	68788770503	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68788-7705-3)	2020-05-01	0000-00-00	No	No	Current