Estring System
NDC 0013-1042
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Estring (estradiol) is a NDA-approved product labeled by Pfizer Laboratories Div Pfizer Inc. This medication is a female hormone (estrogen). It is supplied as a system for vaginal administration. This product entry covers the primary NDC 0013-1042 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0013-1042
Proprietary Name:
Estring
Non-Proprietary Name: [1]
Estradiol
Substance Name: [2]
Estradiol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
System
Administration Route(s): [4]
Vaginal - Administration into the vagina.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0013
Product Label ID:
FDA Application Number: [6]
NDA020472
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
06-05-2023
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0013-1042?
The NDC code 0013-1042 is assigned by the FDA to the product Estring. It is commonly known by its generic name, estradiol. This pharmaceutical product is labeled by Pfizer Laboratories Div Pfizer Inc and is currently categorized as listed product. The medication is a system administered via vaginal route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0013-1042-01. 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 a female hormone (estrogen). It is used by women to help reduce vaginal and urinary symptoms of menopause (such as vaginal dryness/burning/itching, painful urination, frequent urges to urinate). These symptoms are caused by the body making less estrogen. When treating only vaginal symptoms of menopause, products applied directly inside the vagina (such as this medication) should be used first. Estrogens that are taken by mouth, absorbed through the skin, or injected may have greater risks of side effects due to more estrogen being absorbed.
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.
- ESTRADIOL 2 mg/1 - The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- ESTRADIOL (UNII: 4TI98Z838E)
- ESTRADIOL (UNII: 4TI98Z838E) (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:
- BARIUM SULFATE (UNII: 25BB7EKE2E)
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: 848328 - estradiol 2 MG (7.5 MCG per 24HR) 90 Day Vaginal System
- RxCUI: 848328 - 90 DAY estradiol 0.000313 MG/HR Vaginal System
- RxCUI: 848328 - estradiol 0.000313 MG/HR 90 DAY Vaginal System
- RxCUI: 848328 - estradiol 0.0075 MG/24 HR 90 DAY Vaginal System
- RxCUI: 848328 - estradiol 7.5 MCG/24 HR 90 DAY Vaginal System
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.
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".
