ONDANSETRON HYDROCHLORIDE

Product NDC: 51655-800
11-digit product format: 516550800
Labeler code: 51655
Product ID: 51655-800_2b86d942-c970-449f-bd27-bd0ba9ede1c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ONDANSETRON HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northwind Pharmaceuticals
Application: ANDA077851
Marketing category: ANDA
Marketing start: 2014-12-30
Marketing end: 0000-00-00
Substance: ONDANSETRON HYDROCHLORIDE
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-800-04	2026-01-05	C162847	48780-1	9d75b9d0-dda4-f424-e053-dadaa90a57ce	f3ca0e05-0e79-45d5-8597-a41ad9c30310
51655-800-04	2020-01-31	C162847	48780-1	9d75b9d0-dda4-f424-e053-dadaa90a57ce	f3ca0e05-0e79-45d5-8597-a41ad9c30310

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-800	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1	Legacy NDC	20150122_f3ca0e05-0e79-45d5-8597-a41ad9c30310.zip