NDC 16714-441 Sharobel
Norethindrone Kit - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 16714 - Northstar Rx Llc
- 16714-441 - Sharobel
Product Characteristics
Product Packages
NDC Code 16714-441-01
Package Description: 1 BLISTER PACK in 1 PACKET / 1 KIT in 1 BLISTER PACK
Price per Unit: $0.11699 per EA
NDC Code 16714-441-02
Package Description: 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
NDC Code 16714-441-03
Package Description: 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
NDC Code 16714-441-04
Package Description: 6 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Price per Unit: $0.11699 per EA
Product Details
What is NDC 16714-441?
What are the uses for Sharobel?
Which are Sharobel UNII Codes?
The UNII codes for the active ingredients in this product are:
- NORETHINDRONE (UNII: T18F433X4S)
- NORETHINDRONE (UNII: T18F433X4S) (Active Moiety)
Which are Sharobel 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:
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- POLYVINYL ALCOHOL (UNII: 532B59J990)
- TALC (UNII: 7SEV7J4R1U)
- POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
- LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- STARCH, CORN (UNII: O8232NY3SJ)
What is the NDC to RxNorm Crosswalk for Sharobel?
- RxCUI: 1539955 - {28 (norethindrone 0.35 MG Oral Tablet) } Pack [Sharobel 28 Day]
- RxCUI: 1539955 - Sharobel 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.
[Learn More]
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.
[Learn More]
* 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.
[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".