Ondansetron

Product NDC: 0781-5238
11-digit product format: 007815238
Labeler code: 0781
Product ID: 0781-5238_ab451abb-8fef-494f-99b0-6529c55a48c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA078050
Marketing category: ANDA
Marketing start: 2007-08-31
Marketing end: 2020-12-31
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: 0000-00-00
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

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5238-06	EA - Each	0781-5238	40d51021-9e3c-4ae1-b5f0-3c212d2376d6	1	2012-07-24
0781-5238-64	EA - Each	0781-5238	af0b1711-17de-43b3-8e4d-d5d03ded455d	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	2
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	2
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	2

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	ca09dd2c-02ed-4d26-af3c-aaff4120887e	2
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	ca09dd2c-02ed-4d26-af3c-aaff4120887e	2
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	ca09dd2c-02ed-4d26-af3c-aaff4120887e	2
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	ca09dd2c-02ed-4d26-af3c-aaff4120887e	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron Orally Disintegrating Tablets, USP	Physicians Total Care, Inc.	2010-08-20	HUMAN PRESCRIPTION DRUG LABEL	2