ondansetron

Product NDC: 0904-6552
11-digit product format: 009046552
Labeler code: 0904
Product ID: 0904-6552_50aa5f42-2197-43a5-836a-4e0c96209a8b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA076183
Marketing category: ANDA
Marketing start: 2006-12-26
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 8 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#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	8 mg/1

Field, Values table
Field	Values
Unii	NMH84OZK2B
Rxcui	198052, 312086

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6552-61	ondansetron	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		10
0904-6552-61	ondansetron	100 in 1 CARTON	TABLET, FILM COATED	100		10

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6552-61	EA - Each	0904-6552	5a2a029b-1e76-4668-beca-26351c55490f	1	2016-05-16

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6552	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	8	Current NDC, Legacy NDC, 2 package rows	20250416_a29b5c18-9884-4c88-8827-65d9ad5f69f6.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198052	ondansetron HCl 4 MG Oral Tablet	PSN	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
312086	ondansetron HCl 8 MG Oral Tablet	PSN	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
198052	ondansetron 4 MG Oral Tablet	SCD	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
312086	ondansetron 8 MG Oral Tablet	SCD	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	a29b5c18-9884-4c88-8827-65d9ad5f69f6	10
198052	ondansetron HCl 4 MG Oral Tablet	PSN	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6
312086	ondansetron HCl 8 MG Oral Tablet	PSN	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6
198052	ondansetron 4 MG Oral Tablet	SCD	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6
312086	ondansetron 8 MG Oral Tablet	SCD	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6552-61	00904655261	100 BLISTER PACK in 1 CARTON (0904-6552-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2006-12-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ondansetron	Cardinal Health 107, LLC	2026-01-12	HUMAN PRESCRIPTION DRUG LABEL	6
ondansetron	Major Pharmaceuticals	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	10