Hailey Fe 1.5/30
NDC 53002-1812

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 53002-1812?
  5. Hailey Fe 1.5/30 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.

Hailey Fe 1.5/30 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 green product. This product entry covers the primary NDC 53002-1812 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
53002-1812
Proprietary Name:
Hailey Fe 1.5/30
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:
e3f602d6-b863-4e7e-8494-c0aa25d0e5b6
FDA Application Number: [6]
ANDA209031
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
06-05-2018
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I

Product Characteristics

Color(s):
GREEN (C48329 - LIGHT GREEN TO GREEN)
BROWN (C48332 - BROWN TO DARK BROWN)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
Y;12
18;G
Score:
1

Code Structure Chart

Product Details

What is NDC 53002-1812?

The NDC code 53002-1812 is assigned by the FDA to the product Hailey Fe 1.5/30. 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: 53002-1812-1, 53002-1812-3, 53002-1812-6. 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?

Hailey Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE 1LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD% Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous UseMethodLowestExpected*Typical**(No contraception)(85)(85)Oral contraceptives3 Combined0.1N/A*** progestin only0.5N/A***Diaphragm with spermicidal cream or jelly620Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)626Vaginal Sponge nulliparous920 parous2040Implant0.050.05Injection: depot medroxyprogesterone acetate0.30.3IUD progesterone T1.52 copper T 380A0.60.8 LNg 200.10.1Condom without spermicides female521 male314Cervical Cap with spermicidal cream or jelly nulliparous920 parous2640Periodic abstinence (all methods)1 to 925Withdrawal419Female sterilization0.50.5Male sterilization0.10.15Adapted from RA Hatcher et al, Reference 7.*The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.**This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.***N/A-Data not available.

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: 1359022 - norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral Tablet
  • RxCUI: 1359022 - ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet
  • RxCUI: 1359022 - ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral Tablet
  • RxCUI: 1359023 - {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack
  • RxCUI: 1359023 - Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack

* 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".