Tramadol Er
NDC 16590-893
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.
Tramadol Er is a ANDA-approved product labeled by Stat Rx Usa. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 16590-893 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
16590-893
Proprietary Name:
Tramadol Er
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
16590
Product Label ID:
FDA Application Number: [6]
ANDA078783
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
10-27-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
PAR822
Score:
1
Code Structure Chart
Product Details
What is NDC 16590-893?
The NDC code 16590-893 is assigned by the FDA to the product Tramadol Er. This pharmaceutical product is labeled by Stat Rx Usa 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: 16590-893-30, 16590-893-60, 16590-893-90. 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?
INDICATIONS AND USAGETramadol 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 the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK)
- TRAMADOL (UNII: 39J1LGJ30J) (Active Moiety)
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: 833711 - traMADol HCl 200 MG 24HR Extended Release Oral Tablet
- RxCUI: 833711 - 24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet
- RxCUI: 833711 - tramadol HCl 200 MG 24 HR Extended Release Oral Tablet
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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".
