NDC 0009-7667 Cleocin

Clindamycin Phosphate Suppository Vaginal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0009-7667
Proprietary Name:
Cleocin
Non-Proprietary Name: [1]
Clindamycin Phosphate
Substance Name: [2]
Clindamycin Phosphate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route(s): [4]
  • Vaginal - Administration into the vagina.
  • Labeler Name: [5]
    Pharmacia & Upjohn Company Llc
    Labeler Code:
    0009
    FDA Application Number: [6]
    NDA050767
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    08-13-1999
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0009-7667-01

    Package Description: 1 BLISTER PACK in 1 CARTON / 3 SUPPOSITORY in 1 BLISTER PACK

    Price per Unit: $58.94278 per EA

    NDC Code 0009-7667-05

    Package Description: 1 BLISTER PACK in 1 CARTON / 3 SUPPOSITORY in 1 BLISTER PACK

    Product Details

    What is NDC 0009-7667?

    The NDC code 0009-7667 is assigned by the FDA to the product Cleocin which is a human prescription drug product labeled by Pharmacia & Upjohn Company Llc. The generic name of Cleocin is clindamycin phosphate. The product's dosage form is suppository and is administered via vaginal form. The product is distributed in 2 packages with assigned NDC codes 0009-7667-01 1 blister pack in 1 carton / 3 suppository in 1 blister pack, 0009-7667-05 1 blister pack in 1 carton / 3 suppository in 1 blister pack. 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 Cleocin?

    This medication is used to treat a certain type of vaginal infection (bacterial vaginosis) in women who are not pregnant. Clindamycin is an antibiotic which works by stopping the growth of bacteria.

    What are Cleocin 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.

    Which are Cleocin UNII Codes?

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

    Which are the Pharmacologic Classes for Cleocin?

    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.

    Patient Education

    Clindamycin Vaginal


    Vaginal clindamycin is used to treat bacterial vaginosis (an infection caused by an overgrowth of harmful bacteria in the vagina). Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria. Vaginal clindamycin cannot be used to treat vaginal irritation caused by yeast infections or by sexually transmitted diseases such as chlamydia and trichomoniasis.
    [Learn More]


    * 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".