NDC 68405-118 Theraproxen-500

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:
68405-118
Proprietary Name:
Theraproxen-500
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
68405
Start Marketing Date: [9]
03-03-2011
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - LIGHT ORANGE)
GREEN (C48329 - GREEN)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
21 MM
Imprint(s):
G;32;500
;
Score:
2
1

Code Structure Chart

Product Details

What is NDC 68405-118?

The NDC code 68405-118 is assigned by the FDA to the product Theraproxen-500 which is product labeled by Physician Therapeutics Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68405-118-36 1 kit in 1 kit * 90 capsule in 1 bottle * 30 tablet in 1 bottle (52959-193-30). 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 Theraproxen-500?

INDICATIONS AND USAGECarefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Naproxen as naproxen or naproxen sodium tablets are indicated:- For the relief of the signs and symptoms of rheumatoid arthritis- For the relief of the signs and symptoms of osteoarthritis- For the relief of the signs and symptoms of ankylosing spondylitis- For the relief of the signs and symptoms of juvenile arthritisNaproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight.Naproxen as naproxen and naproxen sodium tablets are also indicated:- For relief of the signs and symptoms of tendonitis- For relief of the signs and symptoms of bursitis- For relief of the signs and symptoms of acute gout- For the management of pain- For the management of primary dysmenorrhea INDICATIONS FOR USE  Theramine is intended for the clinical dietary management of the metabolic processes of pain disorders and inflammatory conditions.

Which are Theraproxen-500 UNII Codes?

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

Which are Theraproxen-500 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 Theraproxen-500?

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 code indicates a single concept unique identifier (RXCUI) is 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".