Norgestimate And Ethinyl Estradiol
NDC 53002-1733

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 53002-1733?
  5. Norgestimate And Ethinyl Estradiol Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Norgestimate And Ethinyl Estradiol is a ANDA-approved product labeled by Rpk Pharmaceuticals, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 53002-1733 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
53002-1733
Proprietary Name:
Norgestimate And Ethinyl Estradiol
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Rpk Pharmaceuticals, Inc.
Labeler Code:
53002
Product Label ID:
63e95a36-47e5-4f62-b390-65937744f7f5
FDA Application Number: [6]
ANDA200494
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
06-17-2011
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325 - TO OFF-WHITE)
BLUE (C48333 - LIGHT)
BLUE (C48333)
GREEN (C48329 - LIGHT)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
A9
A8
A7
A2
Score:
1

Code Structure Chart

Product Details

What is NDC 53002-1733?

The NDC code 53002-1733 is assigned by the FDA to the product Norgestimate And Ethinyl Estradiol. This pharmaceutical product is labeled by Rpk Pharmaceuticals, Inc. 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: 53002-1733-1, 53002-1733-3, 53002-1733-6. 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?

Do not prescribe norgestimate and ethinyl estradiol tablets to women who are known to have the following conditions:•A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:∘Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]∘Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]∘Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]∘Have cerebrovascular disease [see Warnings and Precautions (5.1)]∘Have coronary artery disease [see Warnings and Precautions (5.1)]∘Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]∘Have uncontrolled hypertension [see Warnings and Precautions (5.4)]∘Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)] ∘Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.7)]▪Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]•Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)]•Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]•Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)]•Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.11)]•Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)]

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

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:

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: 406396 - norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet
  • RxCUI: 406396 - ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet

* 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".