FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
21922-075
11-digit product format
219220075
Labeler code
21922
Product ID
21922-075_49f5076b-9760-4602-ae1c-a8c071828dbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA076633
Marketing category
ANDA
Marketing start
2025-10-18
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
21922-075-04Fluticasone Propionate15 g in 1 TUBECREAM152
21922-075-04Fluticasone Propionate1 in 1 CARTONCREAM12
21922-075-05Fluticasone Propionate1 in 1 CARTONCREAM12
21922-075-05Fluticasone Propionate30 g in 1 TUBECREAM302
21922-075-07Fluticasone Propionate1 in 1 CARTONCREAM12
21922-075-07Fluticasone Propionate60 g in 1 TUBECREAM602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-075-04GM - Gram21922-0757f34f770-7def-44f1-a474-83471eb416c312026-02-05
21922-075-05GM - Gram21922-0759d0c0754-02a1-4f1e-9bbd-3af9f87429d412026-02-05
21922-075-07GM - Gram21922-075998aaab7-e5e8-428c-972a-aa706b83d89212026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895987fluticasone propionate 0.05 % Topical CreamPSNb734d397-e064-4d13-b0b5-fc89bd87f2e32
895987fluticasone propionate 0.5 MG/ML Topical CreamSCDb734d397-e064-4d13-b0b5-fc89bd87f2e32
895987fluticasone propionate 0.05 % Topical CreamSYb734d397-e064-4d13-b0b5-fc89bd87f2e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-075-04219220075041 TUBE in 1 CARTON (21922-075-04) / 15 g in 1 TUBE1 tube2025-10-18NoNoCurrent
21922-075-05219220075051 TUBE in 1 CARTON (21922-075-05) / 30 g in 1 TUBE1 tube2025-10-18NoNoCurrent
21922-075-07219220075071 TUBE in 1 CARTON (21922-075-07) / 60 g in 1 TUBE1 tube2025-10-18NoNoCurrent