NDC 0009-6582 Cleocin Phosphate (0009-6582) (standalone)

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
0009-6582
Proprietary Name:
Cleocin Phosphate (0009-6582) (standalone)
Product Type: [3]
Labeler Code:
0009
FDA Application Number: [6]
ANDA062803
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
10-16-1987
End Marketing Date: [10]
09-30-2019
Listing Expiration Date: [11]
09-30-2019
Exclude Flag: [12]
D
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Product Details

What is NDC 0009-6582?

The NDC code 0009-6582 is assigned by the FDA to the product Cleocin Phosphate (0009-6582) (standalone) which is product labeled by Pharmacia & Upjohn Company Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0009-6582-01 25 vial in 1 carton / 2 ml in 1 vial (0009-6582-02). 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 Phosphate (0009-6582) (standalone)?

CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.CLEOCIN PHOSPHATE products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.Indicated surgical procedures should be performed in conjunction with antibiotic therapy.CLEOCIN PHOSPHATE is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus.Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes.Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms.Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes.Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms.To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Which are Cleocin Phosphate (0009-6582) (standalone) UNII Codes?

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

Which are Cleocin Phosphate (0009-6582) (standalone) 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:

What is the NDC to RxNorm Crosswalk for Cleocin Phosphate (0009-6582) (standalone)?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product Footnotes

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".