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  4. NDC Product Code: 63548-0197 Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg

NDC 63548-0197 Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg

Ibuprofen,Diphenhydramine Citrate Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63548-0197?
  5. Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

NDC Product Code:
63548-0197
Proprietary Name:
Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg
Non-Proprietary Name: [1]
Ibuprofen, Diphenhydramine Citrate
Substance Name: [2]
Diphenhydramine Citrate; Ibuprofen
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Pld Acquisitions Llc Dba Av�ma Pharma Solutions
    Labeler Code:
    63548
    Product Label ID:
    a7d729bf-6d7a-415a-a414-cae0ba6d0063
    FDA Application Number: [6]
    ANDA211404
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    03-01-2024
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333)
    Shape:
    OVAL (C48345)
    Size(s):
    15 MM
    Imprint(s):
    PL72
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 63548-0197?

    The NDC code 63548-0197 is assigned by the FDA to the product Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg which is a human over the counter drug product labeled by Pld Acquisitions Llc Dba Av�ma Pharma Solutions. The generic name of Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg is ibuprofen, diphenhydramine citrate. The product's dosage form is tablet and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 63548-0197-2 1 bottle, plastic in 1 box / 20 tablet in 1 bottle, plastic, 63548-0197-3 300 tablet in 1 bottle, plastic , 63548-0197-8 8 tablet in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg?

    Do not take more than directedadults and childlren 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours

    What are Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • DIPHENHYDRAMINE CITRATE 38 mg/1 - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
    • IBUPROFEN 200 mg/1 - A non-steroidal anti-inflammatory agent with analgesic, antipyretic, and anti-inflammatory properties

    Which are Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    Which are the Pharmacologic Classes for Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".