NDC 68387-531 Pentazocine And Naloxone

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:
68387-531
Proprietary Name:
Pentazocine And Naloxone
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Keltman Pharmaceuticals Inc.
Labeler Code:
68387
Start Marketing Date: [9]
07-21-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
GREEN (C48329 - LIGHT GREEN)
Shape:
OVAL (C48345)
Size(s):
2 MM
Imprint(s):
WATSON;395;50;05
Score:
2

Product Packages

NDC Code 68387-531-12

Package Description: 120 TABLET in 1 BOTTLE, PLASTIC

NDC Code 68387-531-30

Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

NDC Code 68387-531-60

Package Description: 60 TABLET in 1 BOTTLE, PLASTIC

Product Details

What is NDC 68387-531?

The NDC code 68387-531 is assigned by the FDA to the product Pentazocine And Naloxone which is product labeled by Keltman Pharmaceuticals Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 68387-531-12 120 tablet in 1 bottle, plastic , 68387-531-30 30 tablet in 1 bottle, plastic , 68387-531-60 60 tablet 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 Pentazocine And Naloxone?

Pentazocine and naloxone hydrochlorides tablets are intended for oral use only. Severe, potentially lethal, reactions may result from misuse of pentazocine and naloxone hydrochlorides tablets by injection either alone or in combination with other substances. (See DRUG ABUSE AND DEPENDENCE section.)Pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain.Pentazocine and naloxone hydrochlorides tablets are indicated for oral use only.

Which are Pentazocine And Naloxone UNII Codes?

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

Which are Pentazocine And Naloxone 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 Pentazocine And Naloxone?

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: 312289 - pentazocine 50 MG / naloxone 0.5 MG Oral Tablet
  • RxCUI: 312289 - naloxone 0.5 MG / pentazocine 50 MG Oral Tablet
  • RxCUI: 312289 - naloxone (as naloxone hydrochloride) 0.5 MG / pentazocine (as pentazocine hydrochloride) 50 MG Oral Tablet

* 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".