ONDANSETRON

Product NDC: 63187-670
11-digit product format: 631870670
Labeler code: 63187
Product ID: 63187-670_f302f985-2fc7-4ba8-bcc5-4ff5e4e127dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ONDANSETRON
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077557
Marketing category: ANDA
Marketing start: 2007-08-02
Substance: ONDANSETRON
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077557-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-08-02
A077557-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077557-001	AB
A077557-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A077557-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077557-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077557-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077557-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077557-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077557-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077557-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077557-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077557-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077557-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077557-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077557-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077557-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077557-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077557-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077557-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077557-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077557-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON	4 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
104894	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
9913ed0c-aaad-45e1-b522-98ad170c2e8a	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
63187-670-10	ONDANSETRON	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	3
63187-670-15	ONDANSETRON	15 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	15	3
63187-670-20	ONDANSETRON	20 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	20	3
63187-670-30	ONDANSETRON	30 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	30	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-670-30	EA - Each	63187-670	9792aa63-c73c-4eb3-9621-500963cdd482	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-670	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 4 package rows	20210112_9913ed0c-aaad-45e1-b522-98ad170c2e8a.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	Cardinal Health 107, LLC	26aff90c-49ea-46ac-bbf3-c188c2b061c9	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92c758a3-e749-4a15-be4b-ee30b364b2b0	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ONDANSETRON	ONDANSETRON	Bryant Ranch Prepack	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	b297c163-2052-cb22-e053-2995a90a8289	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	a1dd7420-dd81-2c8e-e053-2995a90ac8e6	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ONDANSETRON	ONDANSETRON	Proficient Rx LP	4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ONDANSETRON	ONDANSETRON	Proficient Rx LP	9913ed0c-aaad-45e1-b522-98ad170c2e8a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557 ndc (product): 63187-670

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
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	9913ed0c-aaad-45e1-b522-98ad170c2e8a	3
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	9913ed0c-aaad-45e1-b522-98ad170c2e8a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-670-10	63187067010	10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-10)	2018-12-01	0000-00-00	No	No	Current
63187-670-15	63187067015	15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-15)	2018-12-01	0000-00-00	No	No	Current
63187-670-20	63187067020	20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-20)	2018-12-01	0000-00-00	No	No	Current
63187-670-30	63187067030	30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-30)	2018-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron Orally Disintegrating Tablets	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3