NDC 21130-808

signature care naproxen sodium pm

Diphenhydramine Hydrochloride, Naproxen Sodium

signature care naproxen sodium pm is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Safeway. The primary component is Diphenhydramine Hydrochloride; Naproxen Sodium.

Product ID21130-808_62ae1f99-df76-4b36-a99c-75e9305be11c
NDC21130-808
Product TypeHuman Otc Drug
Proprietary Namesignature care naproxen sodium pm
Generic NameDiphenhydramine Hydrochloride, Naproxen Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-06-20
Marketing CategoryANDA / ANDA
Application NumberANDA208499
Labeler NameSafeway
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 21130-808-58

1 BOTTLE in 1 CARTON (21130-808-58) > 40 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2019-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21130-808-58 [21130080858]

signature care naproxen sodium pm TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208499
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-20

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:ae48d1aa-2528-4e66-ad78-f2f10df42325
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1550957

    • NDC Crossover Matching brand name "signature care naproxen sodium pm" or generic name "Diphenhydramine Hydrochloride, Naproxen Sodium"

    NDCBrand NameGeneric Name
    21130-808signature care naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    0113-7264basic care naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    72288-310basic care naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    41520-264careone naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    55910-858dg health naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    41163-593equaline naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    49035-727equate all night pain reliefdiphenhydramine hydrochloride, naproxen sodium
    0113-8264good sense naproxen sodiumdiphenhydramine hydrochloride, naproxen sodium
    30142-383naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    30142-753naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    37808-264naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    41250-526naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    36800-264topcare all night pain relief pmdiphenhydramine hydrochloride, naproxen sodium
    11673-687up and up naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
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