FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
71085-090
11-digit product format
710850090
Labeler code
71085
Product ID
71085-090_4d284c43-6b2c-bebf-e063-6394a90af8d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
IPG Pharmaceuticals, Inc.
Application
ANDA077538
Marketing category
ANDA
Marketing start
2026-03-06
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluticasone Propionate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui1797907

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
71085-090-16Fluticasone Propionate1 in 1 CARTONSPRAY, METERED11
71085-090-16Fluticasone Propionate120 in 1 BOTTLE, SPRAYSPRAY, METERED1201
71085-090-32Fluticasone Propionate120 in 1 BOTTLE, SPRAYSPRAY, METERED1201
71085-090-32Fluticasone Propionate2 in 1 CARTONSPRAY, METERED21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71085-090-16GM - Gram71085-090819ffc83-439a-4c04-9ded-e3d93cb2e20212026-04-20
71085-090-32GM - Gram71085-090adef7fbc-41df-415c-bad8-303d62e032f912026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNf1965bd9-1851-4be5-bbe0-71dd59e034d51
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDf1965bd9-1851-4be5-bbe0-71dd59e034d51
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYf1965bd9-1851-4be5-bbe0-71dd59e034d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71085-090-16710850090161 BOTTLE, SPRAY in 1 CARTON (71085-090-16) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2026-03-06NoNoCurrent
71085-090-32710850090322 BOTTLE, SPRAY in 1 CARTON (71085-090-32) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2026-03-06NoNoCurrent