FDA.reportPublic FDA data

Eucrisa

Product NDC
55724-211
11-digit product format
557240211
Labeler code
55724
Product ID
55724-211_e5457495-d465-4c0a-a1ea-603c4c5823fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
crisaborole
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA207695
Marketing category
NDA
Marketing start
2017-01-30
Substance
CRISABOROLE
Active strength
20 mg/g
Pharmacologic classes
Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eucrisa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CRISABOROLE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ2R47HGR7P
Rxcui1865957, 1865962

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
752945ff-66b7-44e5-839e-da21385bcbecProduct name120170309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55724-211-11Eucrisa1 in 1 CARTONOINTMENT113
55724-211-11Eucrisa100 g in 1 TUBEOINTMENT10013
55724-211-21Eucrisa1 in 1 CARTONOINTMENT113
55724-211-21Eucrisa60 g in 1 TUBEOINTMENT6013
55724-211-23Eucrisa1 in 1 CARTONOINTMENT113
55724-211-23Eucrisa60 g in 1 TUBEOINTMENT6013
55724-211-42Eucrisa6 in 1 CARTONOINTMENT613
55724-211-42Eucrisa2.5 g in 1 TUBEOINTMENT2.513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55724-211EUCRISA (CRISABOROLE) OINTMENT [PFIZER LABORATORIES DIV PFIZER INC]12Current NDC, Legacy NDC, 8 package rows20250110_609b77de-1ca3-4783-b8f5-01a9c0f1d77d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1865957crisaborole 2 % Topical OintmentPSN609b77de-1ca3-4783-b8f5-01a9c0f1d77d13
1865962EUCRISA 2 % Topical OintmentPSN609b77de-1ca3-4783-b8f5-01a9c0f1d77d13
1865962crisaborole 0.02 MG/MG Topical Ointment [Eucrisa]SBD609b77de-1ca3-4783-b8f5-01a9c0f1d77d13
1865957crisaborole 0.02 MG/MG Topical OintmentSCD609b77de-1ca3-4783-b8f5-01a9c0f1d77d13
1865957crisaborole 2 % Topical OintmentSY609b77de-1ca3-4783-b8f5-01a9c0f1d77d13
1865962Eucrisa 0.02 MG/MG Topical OintmentSY609b77de-1ca3-4783-b8f5-01a9c0f1d77d13
1865962Eucrisa 2 % Topical OintmentSY609b77de-1ca3-4783-b8f5-01a9c0f1d77d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55724-211-11557240211111 TUBE in 1 CARTON (55724-211-11) / 100 g in 1 TUBE1 tube2017-01-300000-00-00NoNoCurrent
55724-211-21557240211211 TUBE in 1 CARTON (55724-211-21) / 60 g in 1 TUBE1 tube2017-01-300000-00-00NoNoCurrent
55724-211-23557240211231 TUBE in 1 CARTON (55724-211-23) / 60 g in 1 TUBE1 tube2017-01-300000-00-00NoNoCurrent
55724-211-42557240211426 TUBE in 1 CARTON (55724-211-42) / 2.5 g in 1 TUBE6 tube2017-01-300000-00-00NoNoCurrent