Rapidol Naproxen

Product NDC
55758-320
11-digit product format
557580320
Labeler code
55758
Product ID
55758-320_ee13f284-4694-06e2-e053-2a95a90a16ce
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Pharmadel LLC
Application
ANDA091353
Marketing category
ANDA
Marketing start
2021-01-18
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-320-01557580320012 TABLET, COATED in 1 POUCH (55758-320-01) 2021-01-180000-00-00NoNoCurrent
55758-320-505575803205025 POUCH in 1 CARTON (55758-320-50) > 2 TABLET, COATED in 1 POUCH (55758-320-01) 25 pouch2021-01-180000-00-00NoNoCurrent