ONDANSETRON

Product NDC: 51655-803
11-digit product format: 516550803
Labeler code: 51655
Product ID: 51655-803_ae78a4b7-4973-4962-b515-2db14e716dce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northwind Pharmaceuticals, LLC
Application: ANDA077851
Marketing category: ANDA
Marketing start: 2015-02-23
Marketing end: 0000-00-00
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: 2019-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-803-27	2026-01-05	C162847	48780-1	9d75b9d1-0d53-f424-e053-dadaa90a57ce	c4cac92d-f59c-4cf4-940a-4ac2474de5bb
51655-803-27	2020-01-31	C162847	48780-1	9d75b9d1-0d53-f424-e053-dadaa90a57ce	c4cac92d-f59c-4cf4-940a-4ac2474de5bb

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-803	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1	Legacy NDC	20150321_c4cac92d-f59c-4cf4-940a-4ac2474de5bb.zip