Wiki Difference between J9196 and J9201 - Gemcitabine?

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J9201 is gemcitabine with a strength of 38 mg/mL (200 mg/vial, as seen below):

image.jpg

So, anything therapeutically equivalent must have the same strength (among other criteria):

FDA classifies as therapeutically equivalent those drug products that meet the following general criteria: (1) they are approved as safe and effective; (2) they are pharmaceutical equivalents in that they (a) contain identical amounts of the identical active drug ingredient in the identical dosage form and route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled; and (5) they are manufactured in compliance with Current Good Manufacturing Practice regulations. The concept of therapeutic equivalence applies only to drug products containing the identical active ingredient(s) and does not encompass a comparison of different therapeutic agents used for the same condition (e.g., meperidine hydrochloride vs. morphine sulfate for the treatment of pain)
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There is other gemcitabine with a different strength. That would not be therapeutically equivalent to J9201; therefore, it would not be coded using J9201.

J9196 is for gemcitabine manufactured [for] Accord. For example,

gemcitabine-accord.jpg

According to the Preparation and Administration instructions, it has a minimum final concentration after dilution of at least 0.1 mg/mL. So, it is not therapeutically equivalent to the 38 mg/mL of J9201.

2.6 Preparation and Administration
Gemcitabine Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

Exercise caution and wear gloves when preparing Gemcitabine Injection solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if Gemcitabine Injection contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption.

Preparation

Inspect solution and discard vial if particulate matter or discoloration is observed.
Dilute Gemcitabine Injection with 0.9% Sodium Chloride Injection to a minimum final concentration of at least 0.1 mg/mL.
Mix diluted solution by gentle inversion. Do not shake.
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xXxPARAGONxXx said:
J9201 is gemcitabine with a strength of 38 mg/mL (200 mg/vial, as seen below):

View attachment 7145

So, anything therapeutically equivalent must have the same strength (among other criteria):



There is other gemcitabine with a different strength. That would not be therapeutically equivalent to J9201; therefore, it would not be coded using J9201.

J9196 is for gemcitabine manufactured [for] Accord. For example,

View attachment 7147

According to the Preparation and Administration instructions, it has a minimum final concentration after dilution of at least 0.1 mg/mL. So, it is not therapeutically equivalent to the 38 mg/mL of J9201.
Click to expand...
Thank you for this information. Are both J-codes used to treat bladder cancer?
 
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