NDC 62011-0396

Naproxen Sodium PM

Naproxen Sodium

Naproxen Sodium PM is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Strategic Sourcing Services Llc. The primary component is Diphenhydramine Hydrochloride; Naproxen Sodium.

Product ID62011-0396_2f5ffa22-168c-43c9-b5fe-7e93f6c2aa1a
NDC62011-0396
Product TypeHuman Otc Drug
Proprietary NameNaproxen Sodium PM
Generic NameNaproxen Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA209726
Labeler NameStrategic Sourcing Services LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active Ingredient Strength25 mg/1; mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 62011-0396-1

1 BOTTLE, PLASTIC in 1 BOX (62011-0396-1) > 20 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date2019-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62011-0396-1 [62011039601]

Naproxen Sodium PM TABLET
Marketing CategoryANDA
Application NumberANDA209726
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-31

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM220 mg/1

OpenFDA Data

SPL SET ID:7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1550957
    • UPC Code
  • 0052569142516

    • NDC Crossover Matching brand name "Naproxen Sodium PM" or generic name "Naproxen Sodium"

    NDCBrand NameGeneric Name
    70677-0064Naproxen Sodium PMNaproxen Sodium PM
    55315-844Naproxen Sodium PMNaproxen Sodium PM
    55910-854Naproxen Sodium PMNaproxen Sodium PM
    62011-0396Naproxen Sodium PMNaproxen Sodium PM
    30142-753naproxen sodium pmnaproxen sodium pm
    30142-383naproxen sodium pmnaproxen sodium pm
    41250-526naproxen sodium pmnaproxen sodium pm
    37808-264naproxen sodium pmnaproxen sodium pm
    0280-6000AleveNAPROXEN SODIUM
    0280-6010AleveNAPROXEN SODIUM
    0280-6020AleveNAPROXEN SODIUM
    0280-0041Aleve Headache PainNaproxen Sodium
    0113-7033basic care naproxen sodiumNaproxen Sodium
    0113-7368Basic Care Naproxen SodiumNaproxen Sodium
    0113-7901basic care naproxen sodiumNaproxen Sodium
    0113-0901Good Sense Naproxen SodiumNaproxen Sodium
    0113-1412good sense naproxen sodiumnaproxen sodium
    0113-1773good sense naproxen sodiumNaproxen Sodium
    0113-4368Good Sense Naproxen SodiumNaproxen Sodium
    0280-0270MenstridolNAPROXEN SODIUM
    0143-9908NAPROXENnaproxen sodium
    0143-9916NAPROXENnaproxen sodium
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