Home NDC 69097-661 Fluticasone propionate and Salmeterol
Product NDC 69097-661
11-digit product format 690970661
Labeler code 69097
Product ID 69097-661_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 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213087-001 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2026-07-27 A213087-002 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2026-07-27 A213087-003 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2026-07-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A213087-001 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2026-07-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213087-002 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2026-07-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213087-003 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2026-07-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213087-001 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2026-07-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213087-002 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2026-07-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213087-003 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2026-07-27 caaa826d4ba7…
Observed Orange Book normalized TE history# 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 Ingredient Strength FLUTICASONE PROPIONATE 250 ug/1 SALMETEROL XINAFOATE 50 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O2GMZ0LF5W Internal UNII lookup 6EW8Q962A5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 896184 Internal RxNorm lookup 896209 Internal RxNorm lookup 896228 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69097-661-03 69097066103 1 INHALER in 1 CARTON (69097-661-03) / 60 POWDER in 1 INHALER 1 inhaler 2026-07-27 No No Current