NDC 21695-143 Ultracet

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:
21695-143
Proprietary Name:
Ultracet
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rebel Distributors Corp
Labeler Code:
21695
Start Marketing Date: [9]
08-15-2001
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - LIGHT YELLOW)
Shape:
OVAL (C48345)
Size(s):
15 MM
Imprint(s):
O;M;650
Score:
1

Product Packages

NDC Code 21695-143-72

Package Description: 120 TABLET in 1 BOTTLE

Product Details

What is NDC 21695-143?

The NDC code 21695-143 is assigned by the FDA to the product Ultracet which is product labeled by Rebel Distributors Corp. The product's dosage form is . The product is distributed in a single package with assigned NDC code 21695-143-72 120 tablet 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 Ultracet?

See also Warning section. This product is used to treat moderate to moderately severe pain. It contains 2 medications: tramadol and acetaminophen. Tramadol is similar to opioid analgesics. It works in the brain to change how your body feels and responds to pain. Acetaminophen is used to relieve pain, and it can also reduce a fever.

Which are Ultracet UNII Codes?

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

Which are Ultracet 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 Ultracet?

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: 836395 - traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 836395 - acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet
  • RxCUI: 836395 - APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet
  • RxCUI: 836397 - ULTRACET 37.5 MG / 325 MG Oral Tablet
  • RxCUI: 836397 - acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet [Ultracet]

* 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".