Coding Generics

[diana.papshev]

Anonymous member question:

"In the past, we have had issues with miscoding of single-source versus multisource generics as determined by our claims processor. Is there a way we could proactively check to make sure that generics are coded properly?”

[diana.papshev]

Technically, there are two types of generics:

1. Generics marketed under their own ANDAs
2. Authorized generics marketed under the innovators NDAs

However, plans may very in their definition of a multi-source generic. Some plans use the same category to define authorized generics as the innovator brand drugs. Other plans may also use different considerations for ANDA-based generics if they are marketed during the 6-month exclusivity (the first generic) and/or if there are no significant differences in price from their innovator brand equivalents.

Those issues aside, there is a structured process you can follow to identify whether a specific NDC # is assigned to a generic drug (ANDA- or NDA-based). It’s well illustrated in the following 3 video examples:

Example 1: Sulfacetamide ophthalmic solution (NDC#: 24208-0670-04) – coded as innovator but looks like it’s miscoded [4-minute video with audio (16.5MB); for best results you may need to increase your audio volume]


Example 2: Ocella tablets (NDC#: 00555-9131-67) – coded as multi-source generic but looks like innovator drug [5-minute video with audio (23MB); for best results you may need to increase your audio volume]


Example 3: Venlafaxine ER tablets (NDC#: 00131-3267-03) – coded as innovator but looks like a generic [4-minute video with audio (20MB); for best results you may need to increase your audio volume]


The following are general steps and tips:

STEP 1 – Go to FDA’s NDC Directory.

STEP 2 – Perform a search by active ingredient or proprietary name.

STEP 3 – Find the entry that corresponds to the NDC # in question (use the product code [the middle 3-4 digits] to search through the search results).

STEP 4 – Locate the FDA Application # assigned to the NDC # in question (appears in the third column).

STEP 5 – Go to Drugs@FDA.

STEP 6 – Perform a search by the FDA Application #.

STEP 7 – Review results.

- If the FDA Application is categorized as ANDA, it’s an ANDA-based generic.
- If the FDA Application is categorized as NDA, proceed to step 8.

STEP 8 – For cases when the FDA Application is categorized as NDA, compare marketed name (associated with the NDC #) and the drug name/brand name assigned to the FDA Application.

- If the marketed and application brand names match, it’s an innovator brand.
- If the marketed and application brand names do not match, it’s an authorized generic and for verification proceed to step 9

STEP 9 – Go to the FDA’s Listing of Authorized Generics.

STEP 10 – Find brand drug to see if an authorized generic has been introduced (caution: this list is updated on a quarterly basis and it does not capture when and whether authorized generics were discontinued).