FDA.reportPublic FDA data

Fluticasone propionate and Salmeterol

Product NDC
69097-663
Requested package NDC
69097-663-03
11-digit product format
690970663
Labeler code
69097
Product ID
69097-663_6a4f271b-bc4d-4e04-b5d2-d8e8a48d7215
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone propionate and Salmeterol
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
Cipla USA Inc.
Application
ANDA213087
Marketing category
ANDA
Marketing start
2026-07-27
Substance
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength
500; 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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213087-001FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-07-27
A213087-002FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-07-27
A213087-003FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-07-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A213087-001AB
A213087-002AB
A213087-003AB

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 22:38:342026-08A213087-001FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-07-2784e616aacf4f…
2026-09-14 22:38:342026-08A213087-002FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-07-2784e616aacf4f…
2026-09-14 22:38:342026-08A213087-003FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-07-2784e616aacf4f…
2026-08-18 06:07:402026-07A213087-001FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-07-27caaa826d4ba7…
2026-08-18 06:07:402026-07A213087-002FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-07-27caaa826d4ba7…
2026-08-18 06:07:402026-07A213087-003FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2026-07-27caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213087-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213087-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213087-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A213087-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213087-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213087-003AB1caaa826d4ba7…

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 and Salmeterol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE500 ug/1
SALMETEROL XINAFOATE50 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
896184Internal RxNorm lookup
896209Internal RxNorm lookup
896228Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1349a04c-2024-42b9-b81d-a7d995716adeAvailable on FDA.report

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 SALMETEROLCipla USA Inc.1349a04c-2024-42b9-b81d-a7d995716ade2026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213087
application number: ANDA213087
ndc (package): 69097-663-03
ndc (product): 69097-663
ndc11 (package): 69097066303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-663-03690970663031 INHALER in 1 CARTON (69097-663-03) / 60 POWDER in 1 INHALER1 inhaler2026-07-27NoNoCurrent