FDA.reportPublic FDA data

Fluticasone Propionate and Salmeterol

Product NDC
0527-6011
11-digit product format
005276011
Labeler code
0527
Product ID
0527-6011_f418af21-42ab-4af0-bc6f-1079059c07fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate and salmeterol
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
Lannett Company, Inc.
Application
ANDA214464
Marketing category
ANDA
Marketing start
2024-11-29
Substance
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength
250; 50 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214464-001FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-01-12
A214464-002FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-01-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214464-001AB
A214464-002AB

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
2026-02-19 14:30 UTC2026-02A214464-001FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-01-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214464-002FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-01-12011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214464-001FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-01-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214464-002FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-01-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214464-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214464-002AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214464-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214464-002AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALMETEROL XINAFOATE250 ug/1
FLUTICASONE PROPIONATE50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O2GMZ0LF5WInternal UNII lookup
6EW8Q962A5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
896184Internal RxNorm lookup
896209Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c1680db-16e9-4658-977b-110631f95a65Available 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
811691fa-281f-6d95-fb49-e2337fb2e146Product 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
0527-6011-06Fluticasone Propionate and Salmeterol60 in 1 INHALERPOWDER607
0527-6011-06Fluticasone Propionate and Salmeterol1 in 1 CARTONPOWDER17

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone Propionate and SalmeterolFLUTICASONE PROPIONATE AND SALMETEROLLannett Company, Inc.9c1680db-16e9-4658-977b-110631f95a652026-03-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214464
application number: ANDA214464
ndc (product): 0527-6011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896184fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN9c1680db-16e9-4658-977b-110631f95a657
896209fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN9c1680db-16e9-4658-977b-110631f95a657
89618460 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD9c1680db-16e9-4658-977b-110631f95a657
89620960 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD9c1680db-16e9-4658-977b-110631f95a657
896184fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY9c1680db-16e9-4658-977b-110631f95a657
896209fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY9c1680db-16e9-4658-977b-110631f95a657
896184fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY9c1680db-16e9-4658-977b-110631f95a657
896209fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY9c1680db-16e9-4658-977b-110631f95a657

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0527-6011-06005276011061 INHALER in 1 CARTON (0527-6011-06) / 60 POWDER in 1 INHALER1 inhaler2026-01-12NoNoCurrent