imiquimod

Product NDC
0168-0432
11-digit product format
001680432
Labeler code
0168
Product ID
0168-0432_fdbbf340-e87c-44ed-9274-148846ffd788
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imiquimod
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA078548
Marketing category
ANDA
Marketing start
2010-02-25
Marketing end
0000-00-00
Substance
IMIQUIMOD
Active strength
50 mg/g
Pharmacologic classes
Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0432-242024-01-30C16284748780-11030e365-5959-111a-e063-dadaa90a10e2a1dfc325-cc63-4347-9497-f6baf874963c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0432-24EA - Each0168-04321dc4a498-8b02-4860-989b-40064739ab8212012-07-24
0168-0432-27EA - Each0168-043221ec68b6-6fb9-4927-84ac-f79964e8625e12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IMIQUIMODACTIVE INGREDIENTP1QW714R7MIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
IMIQUIMODACTIVE MOIETYP1QW714R7MIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0432-240016804322424 PACKET in 1 BOX (0168-0432-24) > .25 g in 1 PACKET (0168-0432-27) 24 packet2010-02-250000-00-00NoNoCurrent