FDA.reportPublic FDA data

FLUTICASONE PROPIONATE

Product NDC
72888-141
11-digit product format
728880141
Labeler code
72888
Product ID
72888-141_49fdadf9-f6ac-1fc3-e063-6294a90a2c09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUTICASONE PROPIONATE
Dosage form
SPRAY
Route
NASAL
Labeler
Advagen Pharma Ltd
Application
ANDA218321
Marketing category
ANDA
Marketing start
2025-06-05
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A218321-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2025-06-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218321-001AB

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
2026-09-14 22:38:342026-08A218321-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2025-06-0584e616aacf4f…
2026-08-18 06:07:402026-07A218321-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2025-06-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218321-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2025-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218321-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2025-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A218321-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2025-06-056a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218321-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2025-06-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218321-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A218321-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218321-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218321-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218321-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218321-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O2GMZ0LF5WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1797907Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c1c465c-d008-470e-aa48-8b44bd60751cAvailable on FDA.report

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-141-35FLUTICASONE PROPIONATE120 in 1 BOTTLE, SPRAYSPRAY1202
72888-141-35FLUTICASONE PROPIONATE1 in 1 CARTONSPRAY12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-141-35GM - Gram72888-141941907e3-0290-4faf-b2a7-9440175f8a4f12025-07-08

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEPreferred Pharmaceuticals Inc.8225d521-f1f7-4d21-9095-9a2e1833d1bf2026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218321
application number: ANDA218321
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEAdvagen Pharma Ltd2c1c465c-d008-470e-aa48-8b44bd60751c2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218321
application number: ANDA218321
ndc (product): 72888-141
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATENuCare Pharmaceuticals, Inc.4849c4e5-58ea-972c-e063-6394a90a809c2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218321
application number: ANDA218321

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN2c1c465c-d008-470e-aa48-8b44bd60751c2
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD2c1c465c-d008-470e-aa48-8b44bd60751c2
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY2c1c465c-d008-470e-aa48-8b44bd60751c2
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN4849c4e5-58ea-972c-e063-6394a90a809c1
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD4849c4e5-58ea-972c-e063-6394a90a809c1
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY4849c4e5-58ea-972c-e063-6394a90a809c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72888-141-35728880141351 BOTTLE, SPRAY in 1 CARTON (72888-141-35) / 120 SPRAY in 1 BOTTLE, SPRAY2025-06-05NoNoCurrent