Ondansetron

Product NDC: 68462-105
11-digit product format: 684620105
Labeler code: 68462
Product ID: 68462-105_32177a6a-8c35-4e1c-b7f5-7376b1c1316a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA077535
Marketing category: ANDA
Marketing start: 2007-06-25
Substance: ONDANSETRON HYDROCHLORIDE
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077535-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25
A077535-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25
A077535-003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077535-001	AB
A077535-002	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 4 · 123 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	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 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	A077535-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077535-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077535-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077535-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077535-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077535-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077535-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077535-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077535-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077535-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077535-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077535-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077535-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077535-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077535-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077535-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077535-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077535-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077535-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077535-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077535-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077535-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077535-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077535-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077535-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077535-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077535-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077535-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077535-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077535-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077535-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077535-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077535-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077535-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077535-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077535-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077535-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077535-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077535-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077535-003	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4AF302ESOS	Internal UNII lookup
NMH84OZK2B	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
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
68462-105-30	Ondansetron	30 in 1 BOTTLE	TABLET, FILM COATED	30	17
68462-105-33	Ondansetron	3 in 1 BLISTER PACK	TABLET, FILM COATED	3	17
68462-105-33	Ondansetron	1 in 1 CARTON	TABLET, FILM COATED	1	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-105-30	EA - Each	68462-105	c54eb966-ba3d-46bf-8a3b-a26b6ad32189	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
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 HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]	1
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-105	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	16	Current NDC, Legacy NDC, 3 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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	15d0a711-ef3b-4d93-8fbc-17a45f96af8a	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077535 application number: ANDA077535
Ondansetron	ONDANSETRON	Glenmark Pharmaceuticals Inc., USA	eee5217a-eba8-463a-812d-bf3c66f0934f	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077535 application number: ANDA077535 ndc (product): 68462-105
Ondansetron	ONDANSETRON	Redpharm Drug	300b1916-a3d8-0220-e063-6394a90a6f55	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077535 application number: ANDA077535

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NMH84OZK2B	ONDANSETRON HYDROCHLORIDE	103639-04-9	ONDANSETRON HYDROCHLORIDE
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	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
198052	ondansetron HCl 4 MG Oral Tablet	PSN	300b1916-a3d8-0220-e063-6394a90a6f55	4
198052	ondansetron 4 MG Oral Tablet	SCD	300b1916-a3d8-0220-e063-6394a90a6f55	4
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	300b1916-a3d8-0220-e063-6394a90a6f55	4
198052	ondansetron HCl 4 MG Oral Tablet	PSN	ddf0ba8e-fc37-4829-b55c-9a1a62288dfd	1
198052	ondansetron 4 MG Oral Tablet	SCD	ddf0ba8e-fc37-4829-b55c-9a1a62288dfd	1
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	ddf0ba8e-fc37-4829-b55c-9a1a62288dfd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-105-30	68462010530	30 TABLET, FILM COATED in 1 BOTTLE (68462-105-30)		2007-06-25	0000-00-00	No	No	Current
68462-105-33	68462010533	1 BLISTER PACK in 1 CARTON (68462-105-33) / 3 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2007-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	17
Ondansetron	Redpharm Drug	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	4
Ondansetron	Bryant Ranch Prepack	2022-02-08	HUMAN PRESCRIPTION DRUG LABEL	1001
ONDANSETRON - STAT Rx USA LLC \| PSS World Medical Inc.	STAT Rx USA LLC \| PSS World Medical Inc.	2012-03-01	HUMAN PRESCRIPTION DRUG LABEL	1