Ondansetron

Product NDC: 62135-878
11-digit product format: 621350878
Labeler code: 62135
Product ID: 62135-878_1ba47f65-782d-bcae-e063-6294a90a39a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA077406
Marketing category: ANDA
Marketing start: 2006-12-26
Substance: ONDANSETRON
Active strength: 16 mg/1
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077406-001	ONDANSETRON	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26
A077406-002	ONDANSETRON	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26
A077406-003	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26
A077406-004	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077406-003	AB
A077406-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A077406-001	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077406-002	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077406-003	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077406-004	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077406-001	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077406-002	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077406-003	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077406-004	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077406-001	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077406-002	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077406-003	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077406-004	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077406-001	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077406-002	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077406-003	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077406-004	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077406-001	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077406-002	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077406-003	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077406-004	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077406-001	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077406-002	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077406-003	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077406-004	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077406-001	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077406-002	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077406-003	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077406-004	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077406-001	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077406-002	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077406-003	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077406-004	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077406-001	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077406-002	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077406-003	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077406-004	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077406-001	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077406-002	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2006-12-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077406-003	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077406-004	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2006-12-26	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A077406-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077406-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077406-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077406-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077406-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077406-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077406-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077406-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077406-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077406-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077406-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077406-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077406-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077406-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077406-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077406-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077406-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077406-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077406-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077406-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077406-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077406-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077406-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077406-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077406-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077406-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077406-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077406-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077406-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077406-004	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077406-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077406-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077406-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077406-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077406-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077406-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077406-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077406-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077406-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077406-004	AB	1	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ondansetron
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON	16 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4AF302ESOS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104894	Internal RxNorm lookup
312087	Internal RxNorm lookup
2685489	Internal RxNorm lookup
2685613	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
4c74336c-11ec-420a-80e1-d8e4a8f1c46d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d9bd4853-037c-6968-f4d4-9bb9a0efd1ea	Product name	2	20250722
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296	Product name	1	20201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49	Product name	1	20201015
909480fe-0d18-c1c1-a658-0bd9a7131822	Product name	5	20170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62135-878-30	Ondansetron	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-878	ONDANSETRON TABLET, ORALLY DISINTEGRATING [CHARTWELL RX, LLC]	4	Current NDC, 1 package rows	20240628_4c74336c-11ec-420a-80e1-d8e4a8f1c46d.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
Ondansetron	ONDANSETRON	Lifsa Drugs LLC	c66d63cf-a0e5-4cb5-bdf8-9d1115cba23e	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077406 application number: ANDA077406
Ondansetron	ONDANSETRON	Chartwell RX, LLC	4c74336c-11ec-420a-80e1-d8e4a8f1c46d	2024-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077406 application number: ANDA077406 ndc (product): 62135-878

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2685489	ondansetron 16 MG Disintegrating Oral Tablet	PSN	4c74336c-11ec-420a-80e1-d8e4a8f1c46d	4
2685613	ondansetron 24 MG Disintegrating Oral Tablet	PSN	4c74336c-11ec-420a-80e1-d8e4a8f1c46d	4
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	4c74336c-11ec-420a-80e1-d8e4a8f1c46d	4
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	4c74336c-11ec-420a-80e1-d8e4a8f1c46d	4
2685489	ondansetron 16 MG Disintegrating Oral Tablet	SCD	4c74336c-11ec-420a-80e1-d8e4a8f1c46d	4
2685613	ondansetron 24 MG Disintegrating Oral Tablet	SCD	4c74336c-11ec-420a-80e1-d8e4a8f1c46d	4
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	4c74336c-11ec-420a-80e1-d8e4a8f1c46d	4
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	4c74336c-11ec-420a-80e1-d8e4a8f1c46d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
62135-878-30	62135087830	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-878-30)	2024-06-20	No	No	Current