Hydroxyprogesterone Caproate
NDC 47335-037
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.
Hydroxyprogesterone Caproate is a ANDA-approved product labeled by Sun Pharmaceutical Industries, Inc.. This medication is used in women who are pregnant with a single baby, and who have delivered a baby too early (preterm) in the past. It is supplied as a product. This product entry covers the primary NDC 47335-037 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
47335-037
Proprietary Name:
Hydroxyprogesterone Caproate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
47335
Product Label ID:
FDA Application Number: [6]
ANDA208381
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
07-01-2019
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 47335-037?
The NDC code 47335-037 is assigned by the FDA to the product Hydroxyprogesterone Caproate. This pharmaceutical product is labeled by Sun Pharmaceutical Industries, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 47335-037-40. 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 in women who are pregnant with a single baby, and who have delivered a baby too early (preterm) in the past. It is used to help lower the risk of having a preterm baby again. Hydroxyprogesterone is a man-made form of a female hormone (progestin). It is not known how it works to prevent preterm births. This medication is not intended to prevent preterm birth in women pregnant with more than one baby (such as twins, triplets). It is also not intended to stop active preterm labor.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- HYDROXYPROGESTERONE CAPROATE (UNII: 276F2O42F5)
- HYDROXYPROGESTERONE (UNII: 21807M87J2) (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:
- BENZYL ALCOHOL (UNII: LKG8494WBH)
- BENZYL BENZOATE (UNII: N863NB338G)
- CASTOR OIL (UNII: D5340Y2I9G)
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: 1087964 - HYDROXYprogesterone caproate 250 MG/ML Injectable Solution
- RxCUI: 1087964 - hydroxyprogesterone caproate (USP) 250 MG/ML Injectable Solution
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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".
