ONDANSETRON

Product NDC: 62135-350
11-digit product format: 621350350
Labeler code: 62135
Product ID: 62135-350_06fce9d8-ee18-4486-e063-6394a90aeeb4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ONDANSETRON
Dosage form: TABLET
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA077303
Marketing category: ANDA
Marketing start: 2007-06-25
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 4 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077303-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25
A077303-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25
A077303-004	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077303-001	AB
A077303-002	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 4 · 123 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	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077303-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077303-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		RS	2007-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077303-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	A077303-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077303-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077303-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077303-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077303-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077303-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077303-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077303-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077303-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077303-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077303-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077303-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077303-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077303-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077303-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077303-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077303-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077303-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077303-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077303-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077303-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077303-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077303-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077303-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077303-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077303-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077303-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077303-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077303-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077303-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077303-004	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077303-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077303-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077303-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077303-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077303-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077303-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077303-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077303-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077303-001	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 HYDROCHLORIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NMH84OZK2B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198052	Internal RxNorm lookup
312086	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
88b7432b-f5a7-40f3-9b0c-e7b125f5103c	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62135-350-05	ONDANSETRON	500 in 1 BOTTLE	TABLET	500		3
62135-350-30	ONDANSETRON	30 in 1 BOTTLE	TABLET	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-350-05	EA - Each	62135-350	6dea54de-14f0-4e52-8d8e-072cf99a07bb	1	2022-05-04
62135-350-30	EA - Each	62135-350	78f7ccf0-77d4-489d-8c7d-2f0e2bc132f2	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-350	ONDANSETRON TABLET [CHARTWELL RX, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20231006_88b7432b-f5a7-40f3-9b0c-e7b125f5103c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONDANSETRON	ONDANSETRON	Chartwell RX, LLC	88b7432b-f5a7-40f3-9b0c-e7b125f5103c	2023-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077303 application number: ANDA077303 ndc (product): 62135-350

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NMH84OZK2B	ONDANSETRON HYDROCHLORIDE	103639-04-9	ONDANSETRON HYDROCHLORIDE
4AF302ESOS	ONDANSETRON	99614-02-5	ONDANSETRON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198052	ondansetron HCl 4 MG Oral Tablet	PSN	88b7432b-f5a7-40f3-9b0c-e7b125f5103c	3
312086	ondansetron HCl 8 MG Oral Tablet	PSN	88b7432b-f5a7-40f3-9b0c-e7b125f5103c	3
198052	ondansetron 4 MG Oral Tablet	SCD	88b7432b-f5a7-40f3-9b0c-e7b125f5103c	3
312086	ondansetron 8 MG Oral Tablet	SCD	88b7432b-f5a7-40f3-9b0c-e7b125f5103c	3
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	88b7432b-f5a7-40f3-9b0c-e7b125f5103c	3
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	88b7432b-f5a7-40f3-9b0c-e7b125f5103c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62135-350-05	62135035005	500 TABLET in 1 BOTTLE (62135-350-05)	500 tablet	2022-04-20	0000-00-00	No	No	Current
62135-350-30	62135035030	30 TABLET in 1 BOTTLE (62135-350-30)	30 tablet	2022-04-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ONDANSETRON	Chartwell RX, LLC \| Chartwell Pharmaceuticals Congers, LLC	2023-10-05	HUMAN PRESCRIPTION DRUG LABEL	3