ondansetron

Product NDC: 0904-6552
11-digit product format: 009046552
Labeler code: 0904
Product ID: 0904-6552_c966171f-89bb-402a-b56a-fcc3f43df9f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA076183
Marketing category: ANDA
Marketing start: 2006-12-26
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 8 mg/1
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A076183-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26
A076183-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26
A076183-003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26
A076183-004	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		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
A076183-002	AB
A076183-003	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 · 176 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
2026-10-15 13:18:30	2026-09	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 98 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076183-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076183-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076183-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076183-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076183-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076183-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076183-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076183-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076183-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076183-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076183-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076183-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076183-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076183-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076183-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076183-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076183-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076183-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: ondansetron
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	8 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
a29b5c18-9884-4c88-8827-65d9ad5f69f6	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
0904-6552-61	ondansetron	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		10
0904-6552-61	ondansetron	100 in 1 CARTON	TABLET, FILM COATED	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6552-61	EA - Each	0904-6552	5a2a029b-1e76-4668-beca-26351c55490f	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6552	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	8	Current NDC, Legacy NDC, 2 package rows	20250416_a29b5c18-9884-4c88-8827-65d9ad5f69f6.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ondansetron	ONDANSETRON HYDROCHLORIDE	Major Pharmaceuticals	a29b5c18-9884-4c88-8827-65d9ad5f69f6	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183 ndc (product): 0904-6552
ondansetron	ONDANSETRON HYDROCHLORIDE	Cardinal Health 107, LLC	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183
ONDANSETRON	ONDANSETRON HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	162f2088-9fb1-47e7-b88c-45104be7e7bb	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	00327696-c496-4c83-a63e-9e29fd6246d4	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	cdb2c4b4-a20a-3f8f-e053-2a95a90aaf72	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	476e704c-95ae-4591-94f7-ee4ab827ff13	2021-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NMH84OZK2B	ONDANSETRON HYDROCHLORIDE	103639-04-9	ONDANSETRON HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198052	ondansetron HCl 4 MG Oral Tablet	PSN	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
312086	ondansetron HCl 8 MG Oral Tablet	PSN	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
198052	ondansetron 4 MG Oral Tablet	SCD	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
312086	ondansetron 8 MG Oral Tablet	SCD	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
198052	ondansetron HCl 4 MG Oral Tablet	PSN	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6
312086	ondansetron HCl 8 MG Oral Tablet	PSN	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6
198052	ondansetron 4 MG Oral Tablet	SCD	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6
312086	ondansetron 8 MG Oral Tablet	SCD	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6552-61	00904655261	100 BLISTER PACK in 1 CARTON (0904-6552-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2006-12-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ondansetron	Major Pharmaceuticals	2026-08-21	HUMAN PRESCRIPTION DRUG LABEL	11
ondansetron	Cardinal Health 107, LLC	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	7