FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
72657-159
11-digit product format
726570159
Labeler code
72657
Product ID
72657-159_282e11b5-3962-4e31-87c0-18163fa04f92
Type
HUMAN OTC DRUG
Nonproprietary name
fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
GLENMARK THERAPEUTICS INC., USA
Application
ANDA218742
Marketing category
ANDA
Marketing start
2026-03-16
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
Brand name suffix
ALLERGY RELIEF
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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
72657-159-12Fluticasone PropionateALLERGY RELIEF1 in 1 CARTONSPRAY, METERED12
72657-159-12Fluticasone PropionateALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED1202
72657-159-14Fluticasone PropionateALLERGY RELIEF1 in 1 CARTONSPRAY, METERED12
72657-159-14Fluticasone PropionateALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED1442
72657-159-24Fluticasone PropionateALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED1202
72657-159-24Fluticasone PropionateALLERGY RELIEF2 in 1 CARTONSPRAY, METERED22
72657-159-28Fluticasone PropionateALLERGY RELIEF2 in 1 CARTONSPRAY, METERED22
72657-159-28Fluticasone PropionateALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED1442
72657-159-36Fluticasone PropionateALLERGY RELIEF3 in 1 CARTONSPRAY, METERED32
72657-159-36Fluticasone PropionateALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED1202
72657-159-42Fluticasone PropionateALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED1442
72657-159-42Fluticasone PropionateALLERGY RELIEF3 in 1 CARTONSPRAY, METERED32
72657-159-48Fluticasone PropionateALLERGY RELIEF4 in 1 CARTONSPRAY, METERED42
72657-159-48Fluticasone PropionateALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED1202
72657-159-60Fluticasone PropionateALLERGY RELIEF60 in 1 BOTTLESPRAY, METERED602
72657-159-60Fluticasone PropionateALLERGY RELIEF1 in 1 CARTONSPRAY, METERED12
72657-159-72Fluticasone PropionateALLERGY RELIEF72 in 1 BOTTLESPRAY, METERED722
72657-159-72Fluticasone PropionateALLERGY RELIEF1 in 1 CARTONSPRAY, METERED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-159-12ML - Milliliter72657-1593d2ebf15-b646-4fe8-9f0f-a8165943c9d212026-04-20
72657-159-14ML - Milliliter72657-15906d254c1-b66a-4bcf-bf2c-02b69ed8d95712026-04-20
72657-159-28ML - Milliliter72657-1590ceda1bd-2f45-45da-9142-d46656e0171312026-04-20
72657-159-72ML - Milliliter72657-159d2b6ce8b-ed4d-4ac9-930f-7bdf6a172a9912026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN5494106f-6792-409e-b63f-b63b981409592
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD5494106f-6792-409e-b63f-b63b981409592
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY5494106f-6792-409e-b63f-b63b981409592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72657-159-12726570159121 BOTTLE in 1 CARTON (72657-159-12) / 120 SPRAY, METERED in 1 BOTTLE1 bottle2026-03-16NoNoHistorical
72657-159-14726570159141 BOTTLE in 1 CARTON (72657-159-14) / 144 SPRAY, METERED in 1 BOTTLE1 bottle2026-03-16NoNoHistorical
72657-159-24726570159242 BOTTLE in 1 CARTON (72657-159-24) / 120 SPRAY, METERED in 1 BOTTLE2 bottle2026-03-16NoNoHistorical
72657-159-28726570159282 BOTTLE in 1 CARTON (72657-159-28) / 144 SPRAY, METERED in 1 BOTTLE2 bottle2026-03-16NoNoHistorical
72657-159-36726570159363 BOTTLE in 1 CARTON (72657-159-36) / 120 SPRAY, METERED in 1 BOTTLE3 bottle2026-03-16NoNoHistorical
72657-159-42726570159423 BOTTLE in 1 CARTON (72657-159-42) / 144 SPRAY, METERED in 1 BOTTLE3 bottle2026-03-16NoNoHistorical
72657-159-48726570159484 BOTTLE in 1 CARTON (72657-159-48) / 120 SPRAY, METERED in 1 BOTTLE4 bottle2026-03-16NoNoHistorical
72657-159-60726570159601 BOTTLE in 1 CARTON (72657-159-60) / 60 SPRAY, METERED in 1 BOTTLE1 bottle2026-03-16NoNoHistorical
72657-159-72726570159721 BOTTLE in 1 CARTON (72657-159-72) / 72 SPRAY, METERED in 1 BOTTLE1 bottle2026-03-16NoNoHistorical