Ondansetron HCL

Product NDC: 51655-400
11-digit product format: 516550400
Labeler code: 51655
Product ID: 51655-400_3b21ffaa-d097-438d-b14b-f403d9f97608
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron HCL
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Northwind Pharmaceuticals
Application: ANDA077851
Marketing category: ANDA
Marketing start: 2014-03-17
Marketing end: 0000-00-00
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 4 mg/31
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-400-43	2026-01-09	C162847	48780-1	9d75b9d0-a837-f424-e053-dadaa90a57ce	ea33db56-ad0c-40dc-b880-0458aba22862
51655-400-43	2020-01-31	C162847	48780-1	9d75b9d0-a837-f424-e053-dadaa90a57ce	ea33db56-ad0c-40dc-b880-0458aba22862

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-400	ONDANSETRON HCL TABLET, COATED [NORTHWIND PHARMACEUTICALS]	1	Legacy NDC	20140428_ea33db56-ad0c-40dc-b880-0458aba22862.zip