NDC 69238-1422

Naproxen Sodium and Diphenhydramine HCl

Naproxen Sodium And Diphenhydramine

Naproxen Sodium and Diphenhydramine HCl is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Diphenhydramine Hydrochloride; Naproxen Sodium.

Product ID69238-1422_81f89f52-fc3f-43cc-8615-949d2d60e620
NDC69238-1422
Product TypeHuman Otc Drug
Proprietary NameNaproxen Sodium and Diphenhydramine HCl
Generic NameNaproxen Sodium And Diphenhydramine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-23
Marketing CategoryANDA / ANDA
Application NumberANDA209726
Labeler NameAmneal Pharmaceuticals NY 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 69238-1422-2

1 BOTTLE in 1 CARTON (69238-1422-2) > 20 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2018-10-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69238-1422-2 [69238142202]

Naproxen Sodium and Diphenhydramine HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209726
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-23

NDC 69238-1422-4 [69238142204]

Naproxen Sodium and Diphenhydramine HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209726
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-23

NDC 69238-1422-6 [69238142206]

Naproxen Sodium and Diphenhydramine HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209726
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-10-23

NDC 69238-1422-8 [69238142208]

Naproxen Sodium and Diphenhydramine HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209726
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-23

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM220 mg/1

OpenFDA Data

SPL SET ID:caca14cf-95f2-4c60-8bba-2154b8f353a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1550957
    • UPC Code
  • 0369238142266

    • NDC Crossover Matching brand name "Naproxen Sodium and Diphenhydramine HCl" or generic name "Naproxen Sodium And Diphenhydramine"

    NDCBrand NameGeneric Name
    62207-814Naproxen Sodium and Diphenhydramine HClNaproxen Sodium and Diphenhydramine HCl
    69238-1422Naproxen Sodium and Diphenhydramine HClNaproxen Sodium and Diphenhydramine
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.