FDA.reportPublic FDA data

Naproxen

Product NDC
35356-684
11-digit product format
353560684
Labeler code
35356
Product ID
35356-684_7354d28d-dea5-4237-a533-f05ef5f81092
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA074201
Marketing category
ANDA
Marketing start
1993-12-22
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
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-684-20EA - Each35356-6846673d79a-1543-42e1-a594-33819663f08612016-09-02
35356-684-30EA - Each35356-684068441d3-97a4-448d-83b5-e1d567b5153412016-09-02
35356-684-60EA - Each35356-684527388a7-4989-48fc-8ac1-617ad34ae3e512016-09-02
35356-684-90EA - Each35356-684a3137e1f-9b15-44c6-a55b-eccdee28aa2c12016-09-02