Ondansetron

Product NDC: 68001-246
11-digit product format: 680010246
Labeler code: 68001
Product ID: 68001-246_53e876b2-708c-9510-e063-6394a90a1372
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA078152
Marketing category: ANDA
Marketing start: 2014-03-13
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: 2027-12-31
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
A078152-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-06-27
A078152-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078152-001	AB
A078152-002	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 · 86 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	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A078152-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078152-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078152-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078152-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078152-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078152-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078152-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078152-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078152-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078152-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078152-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078152-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078152-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078152-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078152-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078152-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078152-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078152-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078152-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078152-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078152-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078152-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078152-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078152-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078152-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078152-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078152-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078152-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078152-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078152-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078152-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078152-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078152-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078152-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078152-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078152-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078152-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078152-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078152-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078152-002	AB	1	`f41ea6bd6efb…`

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	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104894	Internal RxNorm lookup
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
ed1132ec-c2cd-4646-b69d-26663bb937a4	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
68001-246-04	Ondansetron	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30	15
68001-246-16	Ondansetron	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	15
68001-246-17	Ondansetron	30 in 1 BOX, UNIT-DOSE	TABLET, ORALLY DISINTEGRATING	30	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-246-04	EA - Each	68001-246	5b479d8b-45c5-4fdb-abf7-0d403d663a58	1	2018-05-09
68001-246-16	EA - Each	68001-246	01dbaef5-a363-4bf6-a042-f5a1f40476ff	1	2017-04-05
68001-246-17	EA - Each	68001-246	5b1a7ee6-314d-4638-a3b5-68ee38dabdfe	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]	5
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]	5
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]	5
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-246	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BLUEPOINT LABORATORIES]	13	Current NDC, Legacy NDC, 3 package rows	20220209_ed1132ec-c2cd-4646-b69d-26663bb937a4.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	St. Mary's Medical Park Pharmacy	f175a336-433b-7ab2-e053-2995a90ad5ca	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	c0d827d0-333f-4187-ac75-9dc7d34b6169	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals Inc.	7975d78c-9bb6-467a-9c2d-ea15bde7af5c	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	A-S Medication Solutions	5a81a39b-051b-414e-a6b0-d844de4e9ab4	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	A-S Medication Solutions	02ddd5f5-76d3-4f1c-9af3-d39e05a19c29	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	St. Mary's Medical Park Pharmacy	41366a20-0727-0446-e063-6294a90a957f	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	9c3ad9c1-474e-4331-a017-09cec46702d8	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc	4575d288-be0c-f6c3-e063-6294a90af708	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	3c34ca82-9705-4784-be7c-8b50351d14fc	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals Inc.	e87a5803-e872-43f7-8a15-79aa236e8c07	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	BluePoint Laboratories	ed1132ec-c2cd-4646-b69d-26663bb937a4	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152 ndc (product): 68001-246
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	5bacb621-1261-25d9-e053-2991aa0afa3b	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	df736abd-9cec-4e90-e053-2995a90aab5e	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals, Inc.	50383ef5-6e6e-63a7-e054-00144ff88e88	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	ef6ce203-4ae3-19c9-e053-2995a90af796	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	d117de5f-64e5-464c-b782-de0f07e66c8e	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	Glenmark Pharmaceuticals Inc., USA	eee5217a-eba8-463a-812d-bf3c66f0934f	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	f29f5cfa-3cc4-7d53-e053-2995a90ae844	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	AvKARE	352de988-d166-c2d8-e063-6294a90acc01	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	Proficient Rx LP	81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152

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	ed1132ec-c2cd-4646-b69d-26663bb937a4	15
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	ed1132ec-c2cd-4646-b69d-26663bb937a4	15
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	ed1132ec-c2cd-4646-b69d-26663bb937a4	15
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	ed1132ec-c2cd-4646-b69d-26663bb937a4	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-246-04	68001024604	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68001-246-04)	2018-02-13	0000-00-00	No	No	Current
68001-246-16	68001024616	10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68001-246-16)	2014-03-13	0000-00-00	No	No	Current
68001-246-17	68001024617	30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68001-246-17)	2014-03-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	BluePoint Laboratories \| Glenmark Pharmaceuticals Inc \| Glenmark Pharmaceuticals Limited	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	16