NDC 70677-0064

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 ID70677-0064_891979aa-f275-4b36-bd90-473aaeee9653
NDC70677-0064
Product TypeHuman Otc Drug
Proprietary NameNaproxen Sodium PM
Generic NameNaproxen Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-12-31
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 70677-0064-1

1 BOTTLE, PLASTIC in 1 BOX (70677-0064-1) > 20 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date2018-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70677-0064-1 [70677006401]

Naproxen Sodium PM TABLET
Marketing CategoryANDA
Application NumberANDA209726
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-12-31

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM220 mg/1

OpenFDA Data

SPL SET ID:03a331d8-c957-4949-894f-51d9bd15e0d0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1550957
    • UPC Code
  • 0010939921444

    • 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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