Ondansetron

Product NDC: 53217-382
11-digit product format: 532170382
Labeler code: 53217
Product ID: 53217-382_0af47b75-6c82-4cc4-9f85-df9122faed16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA090469
Marketing category: ANDA
Marketing start: 2018-06-15
Marketing end: 0000-00-00
Substance: ONDANSETRON
Active strength: 4 mg/1
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-382-10	2020-01-31	C162847	48780-1	9d75b9d0-6265-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-382-10	Ondansetron	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-382	ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20180825_a0ba2015-66cd-4c85-825f-e5db642ef95f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4AF302ESOS	ONDANSETRON	99614-02-5	ONDANSETRON

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	a0ba2015-66cd-4c85-825f-e5db642ef95f	1
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	a0ba2015-66cd-4c85-825f-e5db642ef95f	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-382-10	53217038210	10 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-24	HUMAN PRESCRIPTION DRUG LABEL	1