Ondansetron

Product NDC: 68462-158
11-digit product format: 684620158
Labeler code: 68462
Product ID: 68462-158_32177a6a-8c35-4e1c-b7f5-7376b1c1316a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA078152
Marketing category: ANDA
Marketing start: 2007-06-27
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: 2027-12-31
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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`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	A078152-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078152-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078152-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078152-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078152-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078152-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078152-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078152-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078152-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078152-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078152-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078152-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078152-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078152-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078152-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078152-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078152-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078152-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078152-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078152-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078152-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078152-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078152-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078152-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078152-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078152-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078152-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078152-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078152-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078152-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078152-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078152-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078152-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078152-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078152-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078152-002	AB	1	`74a2ff9319b5…`
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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON	8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NMH84OZK2B	Internal UNII lookup
4AF302ESOS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104894	Internal RxNorm lookup
198052	Internal RxNorm lookup
312086	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
eee5217a-eba8-463a-812d-bf3c66f0934f	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-158-11	Ondansetron	10 in 1 BOX, UNIT-DOSE	TABLET, ORALLY DISINTEGRATING	10		17
68462-158-13	Ondansetron	30 in 1 BOX, UNIT-DOSE	TABLET, ORALLY DISINTEGRATING	30		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-158-11	EA - Each	68462-158	96f07cfc-360f-4c96-9204-ff3d0e491def	1	2012-07-24
68462-158-13	EA - Each	68462-158	dd0a48ed-d8d2-4f34-b6e0-9b9da42240ae	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	10
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]	3
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]	3
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]	3
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]	3
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]	3
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]	3
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	2
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]	2
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]	1
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-158	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	16	Current NDC, Legacy NDC, 2 package rows	20240104_eee5217a-eba8-463a-812d-bf3c66f0934f.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	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
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	c0d827d0-333f-4187-ac75-9dc7d34b6169	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
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 ndc (product): 68462-158
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	ST. MARY'S MEDICAL PARK PHARMACY	f175a336-433b-7ab2-e053-2995a90ad5ca	2025-12-05	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
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals Inc.	7975d78c-9bb6-467a-9c2d-ea15bde7af5c	2025-09-03	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
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	d117de5f-64e5-464c-b782-de0f07e66c8e	23
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	d117de5f-64e5-464c-b782-de0f07e66c8e	23
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	5a81a39b-051b-414e-a6b0-d844de4e9ab4	21
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	5a81a39b-051b-414e-a6b0-d844de4e9ab4	21
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	5a81a39b-051b-414e-a6b0-d844de4e9ab4	21
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	5a81a39b-051b-414e-a6b0-d844de4e9ab4	21
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	eee5217a-eba8-463a-812d-bf3c66f0934f	17
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	eee5217a-eba8-463a-812d-bf3c66f0934f	17
198052	ondansetron HCl 4 MG Oral Tablet	PSN	eee5217a-eba8-463a-812d-bf3c66f0934f	17
312086	ondansetron HCl 8 MG Oral Tablet	PSN	eee5217a-eba8-463a-812d-bf3c66f0934f	17
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	eee5217a-eba8-463a-812d-bf3c66f0934f	17
198052	ondansetron 4 MG Oral Tablet	SCD	eee5217a-eba8-463a-812d-bf3c66f0934f	17
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	eee5217a-eba8-463a-812d-bf3c66f0934f	17
312086	ondansetron 8 MG Oral Tablet	SCD	eee5217a-eba8-463a-812d-bf3c66f0934f	17
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	eee5217a-eba8-463a-812d-bf3c66f0934f	17
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	eee5217a-eba8-463a-812d-bf3c66f0934f	17
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74	11
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74	11
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74	11
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74	11
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	f1a0cd50-aa4f-55bc-e053-2995a90a2d3a	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	f1a0ea2c-0788-4e8a-e053-2a95a90a2f32	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	f1a0cd50-aa4f-55bc-e053-2995a90a2d3a	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	f1a0ea2c-0788-4e8a-e053-2a95a90a2f32	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	41366a20-0727-0446-e063-6294a90a957f	2
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	df736abd-9cec-4e90-e053-2995a90aab5e	2
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	41366a20-0727-0446-e063-6294a90a957f	2
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	df736abd-9cec-4e90-e053-2995a90aab5e	2
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	366b4f74-02aa-4f67-a7cb-7362e60e1052	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	c286dba1-e6b1-4cf0-936d-9af42d8eedc3	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	4575d288-be0c-f6c3-e063-6294a90af708	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	40d9cc46-aced-4866-812b-7d82933596ae	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	366b4f74-02aa-4f67-a7cb-7362e60e1052	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	1d0031f0-7def-8b7d-e063-6294a90a26f4	1
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	366b4f74-02aa-4f67-a7cb-7362e60e1052	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	c286dba1-e6b1-4cf0-936d-9af42d8eedc3	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	1d0031f0-7def-8b7d-e063-6294a90a26f4	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	4575d288-be0c-f6c3-e063-6294a90af708	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	40d9cc46-aced-4866-812b-7d82933596ae	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	366b4f74-02aa-4f67-a7cb-7362e60e1052	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-158-11	68462015811	10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68462-158-11)	2007-06-27	0000-00-00	No	No	Current
68462-158-13	68462015813	30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68462-158-13)	2007-06-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	A-S Medication Solutions	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	23
Ondansetron	St. Mary's Medical Park Pharmacy	2026-07-28	HUMAN PRESCRIPTION DRUG LABEL	3
Ondansetron	REMEDYREPACK INC.	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron	NuCare Pharmaceuticals,Inc \| NuCare Pharmaceuticals,Inc.	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron	Preferred Pharmaceuticals Inc.	2026-06-11	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron	NuCare Pharmaceuticals,Inc.	2026-03-13	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron	PD-Rx Pharmaceuticals, Inc.	2026-01-20	HUMAN PRESCRIPTION DRUG LABEL	23
Ondansetron	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	17
Ondansetron Tablets USP, for oral use Ondansetron Orally Disintegrating Tablets USP, for oral use	Proficient Rx LP	2025-11-01	HUMAN PRESCRIPTION DRUG LABEL	11
Ondansetron	Bryant Ranch Prepack	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron ODT	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	3
Ondansetron ODT	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	3
Ondansetron	RedPharm Drug	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	4
Ondansetron	Preferred Pharmaceuticals, Inc.	2019-02-07	HUMAN PRESCRIPTION DRUG LABEL	7
Ondansetron	NuCare Pharmaceuticals,Inc.	2017-07-26	HUMAN PRESCRIPTION DRUG LABEL	1