ondansetron hydrochloride

Product NDC: 62756-130
11-digit product format: 627560130
Labeler code: 62756
Product ID: 62756-130_e83d90db-54a7-4c13-bd68-b1620a8aecaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA077050
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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	NMH84OZK2B, 4AF302ESOS
Rxcui	104894, 198052, 312086, 312087

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	SPL version
62756-130-01	ondansetron hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	18
62756-130-02	ondansetron hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	18
62756-130-02	ondansetron hydrochloride	10 in 1 DOSE PACK	TABLET, FILM COATED	10	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-130-01	EA - Each	62756-130	7ce75d6e-297b-4024-ab7b-c2d94e175498	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
GLYCERYL DISTEARATE	INACTIVE INGREDIENT	73071MW2KM	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-130	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES, INC.]	17	Current NDC, Legacy NDC, 3 package rows	20250419_92c758a3-e749-4a15-be4b-ee30b364b2b0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NMH84OZK2B	ONDANSETRON HYDROCHLORIDE	103639-04-9	ONDANSETRON HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
198052	ondansetron HCl 4 MG Oral Tablet	PSN	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312086	ondansetron HCl 8 MG Oral Tablet	PSN	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
198052	ondansetron 4 MG Oral Tablet	SCD	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312086	ondansetron 8 MG Oral Tablet	SCD	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	13
198052	ondansetron HCl 4 MG Oral Tablet	PSN	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	13
198052	ondansetron 4 MG Oral Tablet	SCD	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	13
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	13
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	13
198052	ondansetron HCl 4 MG Oral Tablet	PSN	69b9a032-f2d1-4c5a-a35e-9cdc3c620716	5
312086	ondansetron HCl 8 MG Oral Tablet	PSN	69b9a032-f2d1-4c5a-a35e-9cdc3c620716	5
198052	ondansetron 4 MG Oral Tablet	SCD	69b9a032-f2d1-4c5a-a35e-9cdc3c620716	5
312086	ondansetron 8 MG Oral Tablet	SCD	69b9a032-f2d1-4c5a-a35e-9cdc3c620716	5
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	69b9a032-f2d1-4c5a-a35e-9cdc3c620716	5
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	69b9a032-f2d1-4c5a-a35e-9cdc3c620716	5
198052	ondansetron HCl 4 MG Oral Tablet	PSN	2e57105a-b925-4182-9f70-d0fa0e613051	2
198052	ondansetron HCl 4 MG Oral Tablet	PSN	badebfae-8a97-419f-bb47-dcd72dcfabe4	2
312086	ondansetron HCl 8 MG Oral Tablet	PSN	2e57105a-b925-4182-9f70-d0fa0e613051	2
198052	ondansetron 4 MG Oral Tablet	SCD	2e57105a-b925-4182-9f70-d0fa0e613051	2
198052	ondansetron 4 MG Oral Tablet	SCD	badebfae-8a97-419f-bb47-dcd72dcfabe4	2
312086	ondansetron 8 MG Oral Tablet	SCD	2e57105a-b925-4182-9f70-d0fa0e613051	2
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	2e57105a-b925-4182-9f70-d0fa0e613051	2
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	badebfae-8a97-419f-bb47-dcd72dcfabe4	2
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	2e57105a-b925-4182-9f70-d0fa0e613051	2
198052	ondansetron HCl 4 MG Oral Tablet	PSN	c5378585-dd35-4123-82b9-91395b56c3eb	1
312086	ondansetron HCl 8 MG Oral Tablet	PSN	c5378585-dd35-4123-82b9-91395b56c3eb	1
198052	ondansetron 4 MG Oral Tablet	SCD	c5378585-dd35-4123-82b9-91395b56c3eb	1
312086	ondansetron 8 MG Oral Tablet	SCD	c5378585-dd35-4123-82b9-91395b56c3eb	1
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	c5378585-dd35-4123-82b9-91395b56c3eb	1
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	c5378585-dd35-4123-82b9-91395b56c3eb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-130-01	62756013001	30 TABLET, FILM COATED in 1 BOTTLE (62756-130-01)		2007-06-25	0000-00-00	No	No	Current
62756-130-02	62756013002	10 BLISTER PACK in 1 DOSE PACK (62756-130-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2007-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ondansetron hydrochloride	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2025-06-12	Human Prescription Drug Label	18
ondansetron hydrochloride	Bryant Ranch Prepack	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	13
Ondansetron Hydrochloride Tablets	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-11-05	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron Hydrochloride Tablets	Physicians Total Care, Inc.	2013-02-21	HUMAN PRESCRIPTION DRUG LABEL	5
Ondansetron Hydrochloride Tablets	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-10-02	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron Hydrochloride Tablets	Rebel Distributors Corp	2010-10-22	HUMAN PRESCRIPTION DRUG LABEL	1

ondansetron hydrochloride

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#