NDC 68258-2003 Tramadol Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
68258-2003
Proprietary Name:
Tramadol Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Dispensing Solutions, Inc.
Labeler Code:
68258
Start Marketing Date: [9]
11-13-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WHITE)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
PAR821
Score:
1

Product Packages

NDC Code 68258-2003-3

Package Description: 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 68258-2003?

The NDC code 68258-2003 is assigned by the FDA to the product Tramadol Hydrochloride which is product labeled by Dispensing Solutions, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68258-2003-3 30 tablet, extended release in 1 bottle, plastic . 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 ER tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

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:

* Please review the disclaimer below.

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".