NAPROXEN SODIUM DS

Product NDC: 42494-400
11-digit product format: 424940400
Labeler code: 42494
Product ID: 42494-400_64efd778-d06c-4289-95f6-ae1fbd6efd35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naproxen sodium
Dosage form: TABLET
Route: ORAL
Labeler: Cameron Pharmaceuticals, LLC
Application: NDA018164
Marketing category: NDA
Marketing start: 2016-07-10
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
Active strength: 550 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: 2017-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42494-400-01	2020-01-31	C162847	48780-1	9d75b9d0-e1b8-f424-e053-dadaa90a57ce	b86b31e9-1726-414a-877e-50079c017339
42494-400-05	2020-01-31	C162847	48780-1	9d75b9d0-e1b8-f424-e053-dadaa90a57ce	b86b31e9-1726-414a-877e-50079c017339

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42494-400-01	EA - Each	42494-400	ca998efc-3eb9-4b01-8d80-63b4a7734dd3	1	2016-09-02

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42494-400	NAPROXEN TABLET EC-NAPROXEN (NAPROXEN) TABLET, DELAYED RELEASE NAPROXEN SODIUM TABLET NAPROXEN SODIUM DS (NAPROXEN SODIUM) TABLET [CAMERON PHARMACEUTICALS, LLC]	2	Legacy NDC	20160813_b86b31e9-1726-414a-877e-50079c017339.zip