Fluticasone Propionate

Product NDC
0363-5012
Requested package NDC
0363-5012-03
11-digit product format
003635012
Labeler code
0363
Product ID
0363-5012_e5dd5bd2-02bf-6c8b-881e-c8283a9021eb
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Walgreens
Application
ANDA208150
Marketing category
ANDA
Marketing start
2018-07-13
Marketing end
2024-02-10
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-50120363-5012-03DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208150-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone PropionateFLUTICASONE PROPIONATEWalgreens16756136-e813-8a91-3351-7e759d1b4b942026-07-30WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEThe Kroger Co.f05689fa-7ff3-0846-c647-bdbe79cb2ff82026-07-29WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEChain Drug Marketing Association, Inc.0d7f6823-a7ef-a6a3-3f4e-3c8618ebccc72026-07-02WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Allergy ReliefFLUTICASONE PROPIONATEP & L Development, LLCf83fabaa-1c6c-4a19-9f30-2f06df6d48f42026-05-26WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Healthf4b9fcfc-f3f7-4ce0-8f97-3d475081aa672026-04-29WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEGrocery Outlet838bbb29-0aa3-4c88-a10d-81be71c202112026-03-16WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEApotex Corp.e3c861e3-2507-9758-fcd0-8e82d721b5b42026-03-06WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATESam's West, Incd2a6e22c-1159-c86a-b927-e7ace1d7023f2025-10-24WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Allergy ReliefFLUTICASONE PROPIONATEDiscount Drug Mart9b6791d9-f8e8-5ae6-fbdd-c96561c0976a2025-09-22WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATESam's West Inc.0370ef12-9199-e2ef-ef85-7d2c7d413bc92025-09-22WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Allergy ReliefFLUTICASONE PROPIONATEQuality Home Products7c81d4d6-d688-72ab-9e43-9b2278d1e0572025-09-22WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEApotex Corp.1252da79-70c1-c46e-e92b-a4edba76b1782025-09-22WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Allergy Relief NasalALLERGY RELIEF NASALMarc Glassman, Inc.bf100c3f-b1f4-4efa-af88-b51ed2a217712025-08-08WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEWalmart8616944c-a684-085a-7106-cf034e3f6f4d2025-07-01WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEBi-Mart3e4ff2eb-0d99-4ce7-910e-81f878b2231e2025-05-22WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATETWIN MED LLC9337aa4b-382d-4ab9-b312-60417cdd40cf2025-05-01WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATETarget Corporationcee73f84-40fb-7143-0f11-4d119de6a9052025-02-13WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Health4250d331-17b0-46be-a779-fb4f09bade162024-04-11WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Healtha4e1c265-5205-4089-8190-0755ede838962023-11-28WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATESelder, S.A. de C.V.2da4ba91-c356-473d-b20c-5bb9265767df2017-11-29WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-5012-01ML - Milliliter0363-50126240fcb9-2e64-4e3c-a4ed-45646ce19e2e12022-06-06
0363-5012-02ML - Milliliter0363-5012998e931b-164f-46a4-aa57-a65dcff7ed0012022-06-06
0363-5012-03ML - Milliliter0363-501230dfd9b9-e2f6-4e5f-85af-91f6777fb2b412022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-5012-03003635012033 BOTTLE, SPRAY in 1 CARTON (0363-5012-03) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY2018-07-132024-02-10NoNoCurrent