ONDANSETRON

Manufacturer: DIRECT RX
Effective date: 2018-09-12
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 20:26:24

Label at a glance#

ProductONDANSETRON

Active ingredientONDANSETRON HYDROCHLORIDE

Label structure3 sections

Indications and uses

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Prevention o...

Label contents#

Full prescribing information#

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy.
Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ONDANESTRON 4 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198052	ondansetron HCl 4 MG Oral Tablet	PSN	2
198052	ondansetron 4 MG Oral Tablet	SCD	2
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ONDANSETRON Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	61919-565-10 AP4L7 01/20		565-10.jpg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-565-10	2020-01-31	C162847	48780-1	9d75b9cf-e06f-f424-e053-dadaa90a57ce	ONDANSETRON 4mg
61919-565-20	2020-01-31	C162847	48780-1	9d75b9cf-e06f-f424-e053-dadaa90a57ce	ONDANSETRON 4mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-565-10	ONDANSETRON	1 in 1 BOTTLE	TABLET, FILM COATED	1		2
61919-565-20	ONDANSETRON	20 in 1 BOTTLE	TABLET, FILM COATED	20		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-565	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	2	Current NDC, Legacy NDC, 2 package rows	20180912_2ebdb67e-d584-0f7b-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-565-10	EA - Each	61919-565	9bd03660-b40a-46ee-83ca-a0b73d6d14ce	1	2018-10-11
61919-565-12	EA - Each	61919-565	97841314-e38b-412e-9068-e0f981a04e60	1	2019-10-07
61919-565-20	EA - Each	61919-565	d8abd4c5-6d43-42e5-bfbd-135a1cadfa7b	1	2016-09-02
61919-565-30	EA - Each	61919-565	7a028dbe-e043-4790-a6dc-d8f0b6e52029	1	2019-09-05
61919-565-45	EA - Each	61919-565	e7c19861-f5ce-48f5-8ec8-40610b315271	1	2026-03-17
61919-565-60	EA - Each	61919-565	bf944937-b4ee-47ec-a850-24c647562d3e	1	2023-05-05
61919-565-90	EA - Each	61919-565	358c8ae6-4ba5-4bd9-b3f6-998d3350fd38	1	2019-09-05
65862-187-03	EA - Each	65862-187	d6020b95-0504-46ea-9728-33616de9c09b	1	2012-07-24
65862-187-05	EA - Each	65862-187	a7af36a8-43aa-4705-a3d7-f894acb7de4d	1	2012-07-24
65862-187-30	EA - Each	65862-187	2e7408a9-dabb-4f66-b627-23db1803aacd	1	2012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

ONDANSETRON
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
TRIACETIN
ONDANSETRON HYDROCHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61919-565	61919-565-20, 61919-565-10
65862-187

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STARCH, CORN	O8232NY3SJ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
TRIACETIN	XHX3C3X673	IACT
ONDANSETRON HYDROCHLORIDE	NMH84OZK2B	ACTIM

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

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	Approval date
A078539-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31
A078539-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31
A078539-003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078539-001	AB
A078539-002	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 · 129 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
2026-09-14 22:38:34	2026-08	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078539-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078539-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078539-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078539-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078539-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078539-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078539-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078539-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078539-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078539-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078539-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078539-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078539-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078539-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078539-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078539-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078539-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078539-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078539-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078539-002	AB	1	`74a2ff9319b5…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONDANSETRON	ONDANSETRON	Direct_Rx	90b73778-2ab5-5460-e053-2a95a90abbc1	2026-02-19	Warnings, Adverse reactions	Exact identifier ndc (product): 61919-565
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Aurobindo Pharma Limited	57578387-1918-4e56-a564-f14fb22340bf	2025-07-19	Warnings, Adverse reactions	Exact identifier ndc (product): 65862-187
75b0c827-08e6-e445-e053-2991aa0a2141			2ebdb67e-d584-0f7b-e054-00144ff8d46c	2018-09-12	Warnings, Adverse reactions	Exact identifier spl id: 75b0c827-08e6-e445-e053-2991aa0a2141 spl set id: 2ebdb67e-d584-0f7b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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