Ondansetron

Product NDC: 71335-2973
Requested package NDC: 71335-2973-3
11-digit product format: 713352973
Labeler code: 71335
Product ID: 71335-2973_0d752116-b9e4-4ee6-a395-0e4a83f892dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209389
Marketing category: ANDA
Marketing start: 2025-06-19
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: 2026-12-31
Current FDA listing: Yes

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

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
A209389-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2023-10-30
A209389-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2023-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209389-001	AB
A209389-002	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 2 · 42 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	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209389-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209389-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-10-30	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209389-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209389-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209389-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209389-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209389-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209389-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209389-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209389-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209389-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209389-002	AB	1	`6a471c1ec25d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209389-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209389-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209389-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209389-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209389-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209389-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209389-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209389-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209389-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209389-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209389-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209389-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209389-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209389-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209389-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209389-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209389-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209389-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209389-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209389-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209389-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209389-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209389-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209389-002	AB	1	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209389-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209389-002	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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON	8 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312087	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
7949c245-b79f-4eaf-a75f-9a17bd7bd307	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	SPL version
71335-2973-1	Ondansetron	90 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	90	1
71335-2973-2	Ondansetron	60 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	60	1
71335-2973-3	Ondansetron	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30	1
71335-2973-4	Ondansetron	14 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	14	1
71335-2973-5	Ondansetron	12 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	12	1
71335-2973-6	Ondansetron	10 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	10	1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	c83821ad-822e-47dc-8108-612312cf3a16	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209389 application number: ANDA209389
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	40258e4b-5e67-46c0-8ef0-3e8bfe36ba11	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209389 application number: ANDA209389
Ondansetron	ONDANSETRON	Ipca Laboratories Limited	8e24f935-87fe-4b6a-b265-60b1039f38d5	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209389 application number: ANDA209389
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	7949c245-b79f-4eaf-a75f-9a17bd7bd307	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209389 application number: ANDA209389 ndc (package): 71335-2973-3 ndc (product): 71335-2973 ndc11 (package): 71335297303

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
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	7949c245-b79f-4eaf-a75f-9a17bd7bd307	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	7949c245-b79f-4eaf-a75f-9a17bd7bd307	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2973-3	71335297303	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-3)	2025-11-06	No	No	Current