Hypermelloses

=Hypermelloses= =Recently, the preferred FDA Substance Registration System (SRS) term "hypromellose" was changed to "hypromelloses." = =This change is related to the preferred term used in the product data elements (drug listing) section of the content of labeling/listing SPL document. This change does NOT affect the utilization of the term "hypromellose" in the content of labeling (package insert or drug facts) sections of an SPL document. = = = =Per the FDA SRS team, the term change more clearly represents the code as being associated with a family of polymers rather than a single substance. The change is intended to encourage SPL authors to choose more granular terms and codes for their listings submissions. = = = =More granular available UNIIs are listed below. The terms also reflect a recent change by USP to SI viscosity units (MPA.S from CPS). = =HYPROMELLOSE 2208 (100 MPA.S) B1QE5P712K = =HYPROMELLOSE 2208 (100000 MPA.S) VM7F0B23ZI = =HYPROMELLOSE 2208 (15000 MPA.S) Z78RG6M2N2 = =HYPROMELLOSE 2208 (3 MPA.S) 9H4L916OBU = =HYPROMELLOSE 2208 (4000 MPA.S) 39J80LT57T = =HYPROMELLOSE 2906 (4000 MPA.S) 5EYA69XGAT = =HYPROMELLOSE 2906 (50 MPA.S) 612E703ZUQ = =HYPROMELLOSE 2910 (15 MPA.S) 36SFW2JZ0W = =HYPROMELLOSE 2910 (15000 MPA.S) 288VBX44JC = =HYPROMELLOSE 2910 (3 MPA.S) 0VUT3PMY82 = =HYPROMELLOSE 2910 (4000 MPA.S) RN3152OP35 = =HYPROMELLOSE 2910 (5 MPA.S) R75537T0T4 = =<span style="font-family: 'Arial','sans-serif'; font-size: 10pt;">HYPROMELLOSE 2910 (50 MPA.S) 1IVH67816N = =<span style="font-family: 'Arial','sans-serif'; font-size: 10pt;">HYPROMELLOSE 2910 (6 MPA.S) 0WZ8WG20P6 = =<span style="font-family: 'Arial','sans-serif'; font-size: 10pt;">ETHYLCELLULOSE (10 MPA.S) 3DYK7UYZ62 = =<span style="font-family: 'Arial','sans-serif'; font-size: 10pt;">ETHYLCELLULOSE (100 MPA.S) 47MLB0F1MV = =<span style="font-family: 'Arial','sans-serif'; font-size: 10pt;">ETHYLCELLULOSE (14 MPA.S) 589D1IWM11 = =<span style="font-family: 'Arial','sans-serif'; font-size: 10pt;">ETHYLCELLULOSE (20 MPA.S) BJG0S321QY = =<span style="font-family: 'Arial','sans-serif'; font-size: 10pt;">ETHYLCELLULOSE (4 MPA.S) KC5472WRJK = =<span style="font-family: 'Arial','sans-serif'; font-size: 10pt;">ETHYLCELLULOSE (45 MPA.S) V7AD894FAZ = =<span style="font-family: 'Arial','sans-serif'; font-size: 10pt;">ETHYLCELLULOSE (50 MPA.S) 6I475159RA = =<span style="font-family: 'Arial','sans-serif'; font-size: 10pt;">ETHYLCELLULOSE (7 MPA.S) H3UP11403C = = = =Note: <span style="font-family: 'Arial','sans-serif'; font-size: 10pt;">It is expected that a similar change will be made for POLYETHYLENE GLYCOL and all other polymers for which the FDA SRS team has created a generic term and code in the very near future. The FDA SRS team has avoided the POLYETHYLENE GLYCOL change because it affects so many products but low molecular weight polyethylene glycols pose significant safety issues so identifying the specific polyethylene glycol is important. If you have any questions or comments regarding this SRS preferred term, please send your questions or comments to spl@fda.hhs.gov. =