NDC 69543-425

NAPROXEN

Naproxen

NAPROXEN is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Virtus Pharmaceuticals, Llc. The primary component is Naproxen.

Product ID69543-425_2c77658c-b5b6-4d22-a218-1334a0d13c02
NDC69543-425
Product TypeHuman Prescription Drug
Proprietary NameNAPROXEN
Generic NameNaproxen
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA091432
Labeler NameVirtus Pharmaceuticals, LLC
Substance NameNAPROXEN
Active Ingredient Strength375 mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69543-425-10

100 TABLET, DELAYED RELEASE in 1 BOTTLE (69543-425-10)
Marketing Start Date2019-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69543-425-10 [69543042510]

NAPROXEN TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091432
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-15

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN375 mg/1

Pharmacological Class

  • Cyclooxygenase Inhibitors [MoA]
  • Anti-Inflammatory Agents
  • Non-Steroidal [CS]
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Cyclooxygenase Inhibitors [MoA]
  • Anti-Inflammatory Agents
  • Non-Steroidal [CS]
  • Nonsteroidal Anti-inflammatory Drug [EPC]

NDC Crossover Matching brand name "NAPROXEN" or generic name "Naproxen"

NDCBrand NameGeneric Name
0054-3630NaproxenNaproxen
0093-1005NaproxenNaproxen
0093-1006NaproxenNaproxen
0143-1346NaproxenNaproxen
0143-1347NaproxenNaproxen
0143-1348NaproxenNaproxen
0143-9908NAPROXENnaproxen sodium
0143-9916NAPROXENnaproxen sodium
0179-1978NaproxenNaproxen
0440-1852NaproxenNaproxen
0440-7852NaproxenNaproxen
0615-1504NaproxenNaproxen
0615-3562NaproxenNaproxen
0615-3563NaproxenNaproxen
0615-7709NaproxenNaproxen
0615-7892NaproxenNaproxen
0615-8094NaproxenNaproxen
10544-010NaproxenNaproxen
10544-016NaproxenNaproxen
10544-019NaproxenNaproxen
10544-044NaproxenNaproxen
10544-061NaproxenNaproxen
10544-111NAPROXENNAPROXEN
10544-277NaproxenNaproxen
10544-278NaproxenNaproxen
10544-614NAPROXENnaproxen sodium
10544-920NaproxenNaproxen
10544-922NaproxenNaproxen
10544-939NaproxenNaproxen
12634-498NaproxenNaproxen
68071-3092NaproxenNaproxen
68071-4006NAPROXENNAPROXEN
68071-3029naproxennaproxen
68071-3066naproxennaproxen
68071-3387NaproxenNaproxen
68071-3345NAPROXENNAPROXEN
68071-4510NAPROXENNAPROXEN
68071-4381NAPROXENNAPROXEN
68134-201NaproxenNaproxen
68151-2894NaproxenNaproxen
68151-2609NaproxenNaproxen
68151-2895NaproxenNaproxen
68382-012NaproxenNaproxen
68382-013NaproxenNaproxen
68382-014NaproxenNaproxen
68387-800NaproxenNaproxen
68387-801NaproxenNaproxen
68387-802NaproxenNaproxen
68462-190NaproxenNaproxen
68462-189NaproxenNaproxen
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