Ondansetron

Product NDC: 63187-526
11-digit product format: 631870526
Labeler code: 63187
Product ID: 63187-526_0507d498-219e-4f9d-b92e-f6fd15657b5a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA090469
Marketing category: ANDA
Marketing start: 2010-04-12
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
A090469-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12
A090469-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090469-001	AB
A090469-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`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	A090469-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090469-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090469-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090469-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090469-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090469-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090469-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090469-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090469-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090469-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090469-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090469-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090469-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090469-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090469-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090469-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090469-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090469-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090469-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090469-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090469-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090469-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090469-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090469-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090469-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090469-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090469-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090469-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090469-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090469-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090469-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090469-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090469-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090469-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090469-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090469-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090469-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090469-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090469-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090469-002	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
f6f2e4ee-dc8b-478d-b0d6-d192119691b7	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
63187-526-03	Ondansetron	3 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	3	10
63187-526-04	Ondansetron	4 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	4	10
63187-526-05	Ondansetron	5 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	5	10
63187-526-06	Ondansetron	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6	10
63187-526-10	Ondansetron	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	10
63187-526-12	Ondansetron	12 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	12	10
63187-526-15	Ondansetron	15 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	15	10
63187-526-20	Ondansetron	20 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	20	10
63187-526-30	Ondansetron	30 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	30	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-526-03	EA - Each	63187-526	95579d95-5dad-455b-aaef-bd645e653509	1	2019-04-11
63187-526-04	EA - Each	63187-526	4ba2143c-b70f-4572-8ddc-fc72e56c2fa0	1	2020-03-10
63187-526-05	EA - Each	63187-526	187285ac-69f1-4d8c-bda0-bb72203a0754	1	2019-06-19
63187-526-06	EA - Each	63187-526	1506d01c-9fb2-4e58-82b8-4a2ce6a5e4ab	1	2019-10-07
63187-526-10	EA - Each	63187-526	6a72c256-07d8-4a60-9fc2-670692249dc0	1	2016-01-13
63187-526-12	EA - Each	63187-526	638b8df2-9858-422f-97d8-d0621288a54f	1	2023-08-08
63187-526-15	EA - Each	63187-526	659f25ae-2612-495a-ace1-7667e5aed635	1	2023-02-06
63187-526-20	EA - Each	63187-526	9803088b-41f6-4630-b8aa-4a6268f2b2de	1	2019-11-12
63187-526-30	EA - Each	63187-526	25a756c5-f8be-442e-8221-2266d5bdda45	1	2019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	1
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-526	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	10	Current NDC, Legacy NDC, 9 package rows	20230623_f6f2e4ee-dc8b-478d-b0d6-d192119691b7.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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	HAWAII REPACK, INC.	b76c5cc9-f1ca-428b-8989-36a66802b650	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	18063a64-a4c0-4bad-911b-00df5c7bb65d	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	77397df5-5a4f-41b2-98bc-f817a1e497fc	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Sportpharm LLC	822404ad-af08-4c62-ae38-7d9819e86079	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	St. Mary's Medical Park Pharmacy	3207cf04-73b7-24ce-e054-00144ff8d46c	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
ONDANSETRON	ONDANSETRON	Direct Rx	b38feff2-900a-4e0c-8260-8f090edbc0bc	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	A-S Medication Solutions	378d0963-d026-4478-8202-fbb636904a37	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Sportpharm LLC	3c4cda2f-13d9-42c5-b449-77deb06c8de5	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	9dff6676-e69e-779d-e053-2995a90a7c81	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	76666e7e-3312-6f9d-e053-2991aa0af705	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	f2b502e2-03ed-fe5c-e053-2995a90a368e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	db9a0d22-9339-4319-e053-2a95a90a9592	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	e07c38c0-e1c2-01de-e053-2995a90a390a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	9558d296-8edd-4aa1-875a-6247f9a8374d	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	10afd68b-877f-4819-a314-39f2d56d5db9	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	66ac9c17-bea7-4f8d-8a27-a1e0f9e65945	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	70b48280-ef74-472b-abc3-128962bfcb05	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	b50c1767-8a50-49ab-be31-6533021ae7c4	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Rising Pharma Holdings, Inc.	eb74425c-c635-4d99-8e98-e63e7359fb89	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469

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	f6f2e4ee-dc8b-478d-b0d6-d192119691b7	10
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	f6f2e4ee-dc8b-478d-b0d6-d192119691b7	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-526-03	63187052603	3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-03)	2019-02-01	0000-00-00	No	No	Current
63187-526-04	63187052604	4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-04)	2019-11-25	0000-00-00	No	No	Current
63187-526-05	63187052605	5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-05)	2019-04-01	0000-00-00	No	No	Current
63187-526-06	63187052606	6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-06)	2019-08-01	0000-00-00	No	No	Current
63187-526-10	63187052610	10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-10)	2015-08-03	0000-00-00	No	No	Current
63187-526-12	63187052612	12 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-526-12)	2023-06-20		No	No	Current
63187-526-15	63187052615	15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-15)	2016-08-01	0000-00-00	No	No	Current
63187-526-20	63187052620	20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-20)	2019-03-01	0000-00-00	No	No	Current
63187-526-30	63187052630	30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-30)	2015-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron Orally Disintegrating Tablets, USP Rx only	Proficient Rx LP	2023-06-01	HUMAN PRESCRIPTION DRUG LABEL	10