NDC 69238-1583 Norlyda
Norethindrone Kit - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 69238 - Amneal Pharmaceuticals Ny Llc
- 69238-1583 - Norlyda
Product Characteristics
Product Packages
NDC Code 69238-1583-6
Package Description: 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Price per Unit: $0.11699 per EA
Product Details
What is NDC 69238-1583?
What are the uses for Norlyda?
Which are Norlyda UNII Codes?
The UNII codes for the active ingredients in this product are:
- NORETHINDRONE (UNII: T18F433X4S)
- NORETHINDRONE (UNII: T18F433X4S) (Active Moiety)
Which are Norlyda 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:
- HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
- HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- POVIDONE (UNII: FZ989GH94E)
- STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
What is the NDC to RxNorm Crosswalk for Norlyda?
- RxCUI: 1811763 - {28 (norethindrone 0.35 MG Oral Tablet) } Pack [Norlyda 28 Day]
- RxCUI: 1811763 - Norlyda 28 Day Pack
- RxCUI: 198042 - norethindrone 0.35 MG Oral Tablet
- RxCUI: 748961 - {28 (norethindrone 0.35 MG Oral Tablet) } Pack
- RxCUI: 748961 - Noreth 0.35 MG (28) Oral Tablet 28 Day Pack
* Please review the disclaimer below.
Patient Education
Norethindrone
Norethindrone is used to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Norethindrone is also used to treat abnormal periods or bleeding and to bring on a normal menstrual cycle in women who menstruated normally in the past but have not menstruated for at least 3 months and who are not pregnant or experiencing menopause (change of life; the end of monthly menstrual periods). Norethindrone is in a class of medications called progestins. It works by stopping the lining of the uterus from growing and by causing the uterus to produce certain hormones. Norethindrone is also used to prevent pregnancy. Norethindrone is sold under different brand names and is taken in smaller amounts when it used to prevent pregnancy. This monograph does not include information on the use of norethindrone to prevent pregnancy. If you are taking norethindrone to prevent pregnancy, read the monograph entitled Progestin-Only (norethindrone) Oral Contraceptives.
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Progestin-Only (norethindrone) Oral Contraceptives
Progestin-only (norethindrone) oral contraceptives are used to prevent pregnancy. Progestin is a female hormone. It works by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus. Progestin-only (norethindrone) oral contraceptives are a very effective method of birth control, but they do not prevent the spread of AIDS and other sexually transmitted diseases.
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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.
[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.
[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.
[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".