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  4. NDC Product Code: 52605-010 Tramadol Hydrochloride

NDC 52605-010 Tramadol Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 52605-010?
  5. Tramadol Hydrochloride 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.
NDC Product Code:
52605-010
Proprietary Name:
Tramadol Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Polygen Pharmaceuticals Inc.
Labeler Code:
52605
Product Label ID:
3606bf61-ad10-49b5-af85-27c7a8c06e70
Start Marketing Date: [9]
06-01-2020
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
13 MM
Imprint(s):
P10
Score:
1

Code Structure Chart

Product Details

What is NDC 52605-010?

The NDC code 52605-010 is assigned by the FDA to the product Tramadol Hydrochloride which is product labeled by Polygen Pharmaceuticals Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 52605-010-01 100 tablet, film coated in 1 bottle , 52605-010-10 1000 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Tramadol Hydrochloride?

Tramadol hydrochloride is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see  Warnings  and  Precautions  (5.1)],  reserve  tramadol hydrochloride  for  use  in  patients  for  whom alternative treatment options [e.g., non-opioid analgesics]: •       Have not been tolerated or are not expected to be tolerated.•       Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Which are Tramadol Hydrochloride UNII Codes?

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

Which are Tramadol Hydrochloride 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:

What is the NDC to RxNorm Crosswalk for Tramadol Hydrochloride?

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:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".