Fluticasone Propionate

Product NDC
53217-164
11-digit product format
532170164
Labeler code
53217
Product ID
53217-164_bc6468db-adb9-4342-ad67-34c18bd6cae0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077055
Marketing category
ANDA
Marketing start
2006-06-30
Marketing end
0000-00-00
Substance
FLUTICASONE PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-164-012020-01-31C16284748780-19d75b9cf-fd73-f424-e053-dadaa90a57ceFluticasone Propionate Cream, USP 0.05% For Dermatologic Use Only-Not for Ophthalmic Use. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-164-01Fluticasone Propionate15 g in 1 TUBECREAM151
53217-164-01Fluticasone Propionate1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-164-01GM - Gram53217-164a25b8492-5f2f-40b0-acbe-d33b3ba0d12212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-164FLUTICASONE PROPIONATE CREAM [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20170221_cf262f35-2018-4e79-bfcf-ed80cc88deef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895987fluticasone propionate 0.05 % Topical CreamPSNcf262f35-2018-4e79-bfcf-ed80cc88deef1
895987fluticasone propionate 0.5 MG/ML Topical CreamSCDcf262f35-2018-4e79-bfcf-ed80cc88deef1
895987fluticasone propionate 0.05 % Topical CreamSYcf262f35-2018-4e79-bfcf-ed80cc88deef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-164-015321701640115 g in 1 TUBE15 gHistorical