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Subject:

Hypermellose or Hypermelloses

Question

Why do I get a validation error when I use the term 'hypermellose'?

Answer

Here are the details


Subject:

UNII Codes - Missing on SPL up on DailyMed

Question

Can an SPL file be posted to DailyMed with some UNII codes missing?

Answer

SPL Release Four (R4) requires the inclusion of all UNIIs for ingredients. If the incoming SPL R4 does not have UNIIs assigned to all ingredients in the product data elements section, the SPL will fail validation.

SPL Release Three (R3) requires UNIIs for active ingredients. If the inactive ingredients in SPL R3 documents have UNIIs, then the FDA system will add them automatically prior to transmitting them to DailyMed. If the inactive ingredient does not have a UNII code, the field(s) will remain blank after transmittal to Daily Med


Subject:

UNII Codes - How to request

Question

How and where can I request a UNII code for a new substance?

Answer

Send an e-mail to spl@fda.hhs.gov . When requesting the assignment of UNIIs to be utilized in SPL documents which contain information for older drugs products associated with applications as well as any new or old non-application drug products, please follow the instructions in section IV(B)(1) of the May 2009 Guidance for Industry - Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing, http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM164053.pdf.)