NDC 0046-0749 Premarin
Conjugated Estrogens Injection, Powder, Lyophilized, For Solution Intramuscular; - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 0046 - Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.
- 0046-0749 - Premarin
Product Packages
NDC Code 0046-0749-05
Package Description: 1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Details
What is NDC 0046-0749?
What are the uses for Premarin?
What are Premarin Active Ingredients?
- ESTROGENS, CONJUGATED 25 mg/5mL - A pharmaceutical preparation containing a mixture of water-soluble, conjugated estrogens derived wholly or in part from URINE of pregnant mares or synthetically from ESTRONE and EQUILIN. It contains a sodium-salt mixture of estrone sulfate (52-62%) and equilin sulfate (22-30%) with a total of the two between 80-88%. Other concomitant conjugates include 17-alpha-dihydroequilin, 17-alpha-estradiol, and 17-beta-dihydroequilin. The potency of the preparation is expressed in terms of an equivalent quantity of sodium estrone sulfate.
Which are Premarin UNII Codes?
The UNII codes for the active ingredients in this product are:
- ESTROGENS, CONJUGATED (UNII: IU5QR144QX)
- ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (Active Moiety)
Which are Premarin 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:
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
What is the NDC to RxNorm Crosswalk for Premarin?
- RxCUI: 211975 - Premarin Intravenous 25 MG Injection
- RxCUI: 211975 - estrogens, conjugated (USP) 25 MG Injection [Premarin]
- RxCUI: 310203 - estrogens, conjugated 25 MG Injection
- RxCUI: 310203 - estrogens, conjugated (USP) 25 MG Injection
Which are the Pharmacologic Classes for Premarin?
* Please review the disclaimer below.
Patient Education
Estrogen Injection
The estradiol cypionate and estradiol valerate forms of estrogen injection are used to treat hot flushes (hot flashes; sudden strong feelings of heat and sweating) and/or vaginal dryness, itching, and burning in women who are experiencing menopause (change of life; the end of monthly menstrual periods). However, women who need a medication only to treat vaginal dryness, itching, or burning should consider a different treatment. These forms of estrogen injection are also sometimes used to treat the symptoms of low estrogen in young women who do not produce enough estrogen naturally. The estradiol valerate form of estrogen injection is also sometimes used to relieve the symptoms of certain types of prostate (a male reproductive organ) cancer. The conjugated estrogens form of estrogen injection is used to treat abnormal vaginal bleeding that a doctor has decided is caused only by a problem with the amounts of certain hormones in the body. Estrogen injection is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.
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* Please review the disclaimer below.
[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".