Oxandrolone
NDC 63629-7603
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Oxandrolone is a ANDA-approved product labeled by Bryant Ranch Prepack. This medication is used to help people regain weight they have lost due to certain medical conditions (such as surgery, chronic infection, trauma, long term use of corticosteroid medication such as hydrocortisone/prednisone). It is supplied as a white product. This product entry covers the primary NDC 63629-7603 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
63629-7603
Proprietary Name:
Oxandrolone
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
63629
Product Label ID:
FDA Application Number: [6]
ANDA077827
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
08-20-2007
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
K200
Score:
2
Code Structure Chart
Product Details
What is NDC 63629-7603?
The NDC code 63629-7603 is assigned by the FDA to the product Oxandrolone. This pharmaceutical product is labeled by Bryant Ranch Prepack and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 63629-7603-1, 63629-7603-2, 63629-7603-3. 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 people regain weight they have lost due to certain medical conditions (such as surgery, chronic infection, trauma, long term use of corticosteroid medication such as hydrocortisone/prednisone). It is also used to relieve bone pain due to bone loss (osteoporosis). Oxandrolone belongs to a class of drugs known as anabolic steroids. These drugs are similar to male hormones made by the body.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- OXANDROLONE (UNII: 7H6TM3CT4L)
- OXANDROLONE (UNII: 7H6TM3CT4L) (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:
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- STARCH, CORN (UNII: O8232NY3SJ)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
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 code indicates a single concept unique identifier (RXCUI) is associated with this product:
- RxCUI: 198056 - oxandrolone 2.5 MG Oral Tablet
* Please review the full disclaimer at the bottom of this page.
Patient Education
Oxandrolone
Oxandrolone is used with a diet program to cause weight gain in people who have lost too much weight due to surgery, injury, chronic (long-lasting) infections, trauma, or who are underweight for unknown reasons. Oxandrolone is also used to treat bone pain in people with osteoporosis (a condition in which the bones become thin and weak and break easily) and to prevent certain side effects in people who take corticosteroids (a group of medications used to treat many conditions that involve inflammation or swelling of part of the body) for a long time. Oxandrolone is in a class of medications called androgenic hormones. It works by increasing the amount of protein made by the body. This protein is used to build more muscle and increase body weight.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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".
