Meloxicam
NDC 42549-513
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Meloxicam is a ANDA-approved product labeled by 4uortho Llc. Meloxicam is used to treat arthritis. It is supplied as a white product. This product entry covers the primary NDC 42549-513 and 10 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
42549-513
Proprietary Name:
Meloxicam
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
42549
Product Label ID:
FDA Application Number: [6]
ANDA077937
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
10-05-2009
End Marketing Date: [10]
03-08-2010
Listing Expiration Date: [11]
03-08-2010
Exclude Flag: [12]
D
Product Characteristics
Color(s):
WHITE (C48325 - WHITE)
BROWN (C48332 - LIGHT CARAMEL-LIGHT CARAMEL)
BROWN (C48332 - LIGHT CARAMEL-LIGHT CARAMEL)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
21 MM
21 MM
Imprint(s):
IP;101
IP;103
Score:
1
Code Structure Chart
Product Details
What is NDC 42549-513?
The NDC code 42549-513 is assigned by the FDA to the product Meloxicam. This pharmaceutical product is labeled by 4uortho Llc and is currently categorized as listed product. In terms of distribution, this product is available in 10 different package configurations. 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?
Meloxicam is used to treat arthritis. It reduces pain, swelling, and stiffness of the joints. Meloxicam is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- GABAPENTIN (UNII: 6CW7F3G59X)
- GABAPENTIN (UNII: 6CW7F3G59X) (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: 310430 - gabapentin 100 MG Oral Capsule
- RxCUI: 310431 - gabapentin 300 MG Oral Capsule
* 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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".
