FDA.reportPublic FDA data

leader fluticasone propionate

Product NDC
70000-0703
11-digit product format
700000703
Labeler code
70000
Product ID
70000-0703_7269e8c3-d42e-48c0-b9b7-34e531fc1ee4
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA207957
Marketing category
ANDA
Marketing start
2024-06-12
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
leader 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
70000-0703-1leader fluticasone propionate1 in 1 CARTONSPRAY, METERED14
70000-0703-1leader fluticasone propionate72 in 1 BOTTLE, SPRAYSPRAY, METERED724
70000-0703-2leader fluticasone propionate144 in 1 BOTTLE, SPRAYSPRAY, METERED1444
70000-0703-2leader fluticasone propionate1 in 1 CARTONSPRAY, METERED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0703-1ML - Milliliter70000-07039d90766d-a62d-45b7-8bfe-6382ccc08e9912025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0703LEADER FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) SPRAY, METERED [CARDINAL HEALTH 110, LLC. DBA LEADER]2Current NDC, 4 package rows20240625_14bb5d74-0384-417e-a06b-8868d85234dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN14bb5d74-0384-417e-a06b-8868d85234dd4
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD14bb5d74-0384-417e-a06b-8868d85234dd4
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY14bb5d74-0384-417e-a06b-8868d85234dd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70000-0703-1700000703011 BOTTLE, SPRAY in 1 CARTON (70000-0703-1) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY2024-06-24NoNoHistorical
70000-0703-2700000703021 BOTTLE, SPRAY in 1 CARTON (70000-0703-2) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY2024-06-12NoNoHistorical