ONDANSETRON

Product NDC: 63304-458
11-digit product format: 633040458
Labeler code: 63304
Product ID: 63304-458_ad113c32-f57c-4548-9882-c46b9a990bd8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ONDANSETRON
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA077851
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077851-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25
A077851-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		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
A077851-001	AB
A077851-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077851-001	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	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077851-001	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	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077851-001	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	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077851-001	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	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077851-001	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	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077851-001	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	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077851-001	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	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077851-001	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	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077851-001	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	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077851-001	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	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077851-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077851-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077851-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077851-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077851-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077851-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077851-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077851-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077851-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077851-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077851-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077851-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077851-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077851-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077851-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077851-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077851-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077851-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077851-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077851-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077851-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077851-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077851-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077851-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077851-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077851-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077851-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077851-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077851-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077851-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077851-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077851-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077851-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077851-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077851-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077851-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077851-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077851-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077851-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077851-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198052	Internal RxNorm lookup
312086	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
834bc56a-657d-4733-9a60-47040cb5c7bf	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	Strength	SPL version
63304-458-30	ONDANSETRON	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-458-30	EA - Each	63304-458	08c42617-c011-4822-897e-e8b6c8bae7d5	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 [PROFICIENT RX LP]	2
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]	2
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HCL TABLET, COATED [NORTHWIND PHARMACEUTICALS]	1
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	1
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	1
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HCL TABLET, COATED [NORTHWIND PHARMACEUTICALS]	1
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	1
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON TABLET, FILM COATED [DIRECT RX]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-458	ONDANSETRON TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20190919_834bc56a-657d-4733-9a60-47040cb5c7bf.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ondansetron	ONDANSETRON HYDROCHLORIDE	Ascend Laboratories, LLC	2edc0788-dc38-4d21-ba8e-71f159e2d3b1	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	36592150-7e19-474c-9f96-cc8341e28b5d	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
Ondansetron	ONDANSETRON	Golden State Medical Supply, Inc.	2b9ea1fc-59a4-8189-e063-6394a90a9ae6	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
Ondansetron	ONDANSETRON	Natco Pharma USA LLC	64527de5-0b92-4340-9243-7a37e8ff96d9	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	f08f56de-8678-4da9-8cae-013a5c393453	2024-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
Ondansetron	ONDANSETRON TABLETS	Natco Pharma Limited	59c817b7-a1c6-48a5-9bfc-2c381532bfd9	2021-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
ondansetron	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	bde7c22c-0047-4735-8df6-b48e8dfa478a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
ONDANSETRON	ONDANSETRON	Proficient Rx LP	41c0dc3d-a616-425e-9073-625a0cb692c4	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
ONDANSETRON	ONDANSETRON	Sun Pharmaceutical Industries, Inc.	834bc56a-657d-4733-9a60-47040cb5c7bf	2019-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851 ndc (product): 63304-458
ondansetron	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	37de0550-a6d1-46a8-a0b8-447b0dcf70ad	2019-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851

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
198052	ondansetron HCl 4 MG Oral Tablet	PSN	4eb5d64c-89ff-4ee4-98ca-487866b8f2e7	5
198052	ondansetron 4 MG Oral Tablet	SCD	4eb5d64c-89ff-4ee4-98ca-487866b8f2e7	5
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	4eb5d64c-89ff-4ee4-98ca-487866b8f2e7	5
198052	ondansetron HCl 4 MG Oral Tablet	PSN	41c0dc3d-a616-425e-9073-625a0cb692c4	4
312086	ondansetron HCl 8 MG Oral Tablet	PSN	41c0dc3d-a616-425e-9073-625a0cb692c4	4
198052	ondansetron 4 MG Oral Tablet	SCD	41c0dc3d-a616-425e-9073-625a0cb692c4	4
312086	ondansetron 8 MG Oral Tablet	SCD	41c0dc3d-a616-425e-9073-625a0cb692c4	4
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	41c0dc3d-a616-425e-9073-625a0cb692c4	4
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	41c0dc3d-a616-425e-9073-625a0cb692c4	4
198052	ondansetron HCl 4 MG Oral Tablet	PSN	834bc56a-657d-4733-9a60-47040cb5c7bf	2
312086	ondansetron HCl 8 MG Oral Tablet	PSN	834bc56a-657d-4733-9a60-47040cb5c7bf	2
198052	ondansetron 4 MG Oral Tablet	SCD	834bc56a-657d-4733-9a60-47040cb5c7bf	2
312086	ondansetron 8 MG Oral Tablet	SCD	834bc56a-657d-4733-9a60-47040cb5c7bf	2
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	834bc56a-657d-4733-9a60-47040cb5c7bf	2
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	834bc56a-657d-4733-9a60-47040cb5c7bf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-458-30	63304045830	30 TABLET, FILM COATED in 1 BOTTLE (63304-458-30)	2007-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ONDANSETRON - Proficient Rx LP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	4
ONDANSETRON	Sun Pharmaceutical Industries, Inc. \| Natco Pharma Limited-Pharma Division	2019-09-11	HUMAN PRESCRIPTION DRUG LABEL	2
ONDANSETRON - REMEDYREPACK INC.	REMEDYREPACK INC.	2016-12-06	HUMAN PRESCRIPTION DRUG LABEL	2
ONDANSETRON	DIRECT RX	2015-12-10	HUMAN PRESCRIPTION DRUG LABEL	5
Ondansetron HCL - Northwind Pharmaceuticals \| Northwind Pharmceuticals	Northwind Pharmaceuticals \| Northwind Pharmceuticals	2014-03-11	HUMAN PRESCRIPTION DRUG LABEL	1