Prepidil Gel
NDC 0009-3359
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Prepidil (dinoprostone) is a NDA-approved product labeled by Pharmacia & Upjohn Company Llc. This medication is used to help prepare your cervix (the lower opening of the womb) for labor and delivery. It is supplied as a gel for vaginal administration. This product entry covers the primary NDC 0009-3359 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0009-3359
Proprietary Name:
Prepidil
Non-Proprietary Name: [1]
Dinoprostone
Substance Name: [2]
Dinoprostone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Gel
- A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s): [4]
Vaginal - Administration into the vagina.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0009
Product Label ID:
FDA Application Number: [6]
NDA019617
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
12-09-1992
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0009-3359?
The NDC code 0009-3359 is assigned by the FDA to the product Prepidil. It is commonly known by its generic name, dinoprostone. This pharmaceutical product is labeled by Pharmacia & Upjohn Company Llc and is currently categorized as listed product. The medication is a gel administered via vaginal route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 0009-3359-01, 0009-3359-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
This medication is used to help prepare your cervix (the lower opening of the womb) for labor and delivery. It is used by women who are having a normal pregnancy and who are at or near their delivery due date. Dinoprostone is a natural substance that your body makes in preparation for labor. It relaxes and softens your cervix (cervical ripening) to allow the baby to pass through the birth canal during delivery.
What are Active Ingredients of this product?
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.
- DINOPROSTONE .5 mg/3g - The most common and most biologically active of the mammalian prostaglandins. It exhibits most biological activities characteristic of prostaglandins and has been used extensively as an oxytocic agent. The compound also displays a protective effect on the intestinal mucosa.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- DINOPROSTONE (UNII: K7Q1JQR04M)
- DINOPROSTONE (UNII: K7Q1JQR04M) (Active Moiety)
Which are the Inactive Ingredients associated 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:
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- TRIACETIN (UNII: XHX3C3X673)
What is the NDC to RxNorm Crosswalk for this product?
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:
- RxCUI: 208397 - Prepidil 0.5 MG per 3 GM Vaginal Gel
- RxCUI: 208397 - dinoprostone 0.000167 MG/MG Vaginal Gel [Prepidil]
- RxCUI: 208397 - PGE2 0.000167 MG/MG Vaginal Gel [Prepidil]
- RxCUI: 208397 - Prepidil 0.000167 MG/MG Vaginal Gel
- RxCUI: 309922 - dinoprostone 0.5 MG in 3 GM Vaginal Gel
Which are the Pharmacologic Classes of this product?
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 full disclaimer at the bottom of this page.
Patient Education
Dinoprostone
Dinoprostone is used to prepare the cervix for the induction of labor in pregnant women who are at or near term. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
