FDA.reportPublic FDA data

FLUTICASONE PROPIONATE

Product NDC
63187-959
11-digit product format
631870959
Labeler code
63187
Product ID
63187-959_1c522e4f-54b7-48b1-899e-5b4290f330b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA076451
Marketing category
ANDA
Marketing start
2004-05-14
Substance
FLUTICASONE PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui895987

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-959-15FLUTICASONE PROPIONATE15 g in 1 TUBECREAM153
63187-959-30FLUTICASONE PROPIONATE30 g in 1 TUBECREAM303
63187-959-60FLUTICASONE PROPIONATE60 g in 1 TUBECREAM603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-959-60GM - Gram63187-95937bbbd2c-d8e8-4027-bc00-6d70b0224aca12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-959FLUTICASONE PROPIONATE CREAM [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191105_96af29b8-16b4-4113-9ec3-338438e11a49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895987fluticasone propionate 0.05 % Topical CreamPSN96af29b8-16b4-4113-9ec3-338438e11a493
895987fluticasone propionate 0.5 MG/ML Topical CreamSCD96af29b8-16b4-4113-9ec3-338438e11a493
895987fluticasone propionate 0.05 % Topical CreamSY96af29b8-16b4-4113-9ec3-338438e11a493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-959-156318709591515 g in 1 TUBE (63187-959-15) 15 g2018-01-010000-00-00NoNoCurrent
63187-959-306318709593030 g in 1 TUBE (63187-959-30) 30 g2018-01-010000-00-00NoNoCurrent
63187-959-606318709596060 g in 1 TUBE (63187-959-60) 60 g2018-01-010000-00-00NoNoCurrent