Naproxen Delayed Release

Product NDC: 51655-628
11-digit product format: 516550628
Labeler code: 51655
Product ID: 51655-628_bf547f77-f9d8-475d-8bf5-4ec40b616b0f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen Delayed Release
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Northwind Pharmaceuticals
Application: ANDA091432
Marketing category: ANDA
Marketing start: 2014-05-16
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 500 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [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
51655-628-52	2026-01-08	C162847	48780-1	9d75b9d0-7c1b-f424-e053-dadaa90a57ce	c66b0b05-84b4-4f0c-82b2-f0c386f6f64f
51655-628-52	2020-01-31	C162847	48780-1	9d75b9d0-7c1b-f424-e053-dadaa90a57ce	c66b0b05-84b4-4f0c-82b2-f0c386f6f64f

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN DELAYED RELEASE TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN DELAYED RELEASE TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-628	NAPROXEN DELAYED RELEASE TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS]	1	Legacy NDC	20140603_c66b0b05-84b4-4f0c-82b2-f0c386f6f64f.zip