fluticasone propionate and salmeterol

Product NDC: 0054-0327
11-digit product format: 000540327
Labeler code: 0054
Product ID: 0054-0327_e2206df8-d8d5-4bef-beff-e70c42419d01
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluticasone propionate and salmeterol
Dosage form: POWDER
Route: RESPIRATORY (INHALATION)
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA203433
Marketing category: ANDA
Marketing start: 2020-12-17
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: 2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17
A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17
A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203433-001	AB
A203433-002	AB
A203433-003	AB

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.

Product history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203433-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203433-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203433-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203433-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203433-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203433-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203433-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203433-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203433-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203433-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: fluticasone propionate and salmeterol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SALMETEROL XINAFOATE	250 ug/1
FLUTICASONE PROPIONATE	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f9fcfc90-3677-4a9b-900e-44417d50d507	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33	Product name	3	20260126
343e8617-eb68-1e10-cfa9-8c30af285764	Product name	3	20240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729	Product name	4	20220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81	Product name	2	20180723
3bcd721e-0555-4bc3-96c6-690471ff9d94	Product name	1	20171113
9f9452df-fa34-43d4-97fe-c6605344c5a8	Product name	1	20171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202	Product name	1	20170426
f3c5232f-03de-44f5-996a-90cd9c08bc60	Product name	1	20170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2	Product name	1	20140508
667f427a-8698-a508-767a-53ed61b4c2e9	Product name	1	20140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9	Product name	1	20140508
6df84e13-2223-fa46-1e26-17e2f58a1e1c	Product name	1	20140508
811691fa-281f-6d95-fb49-e2337fb2e146	Product name	1	20140508
90fec588-984c-4375-cfd4-7e40114bdf80	Product name	1	20140508
9c1d3c48-b162-204b-f55b-e0f25c31c52e	Product name	1	20140508
9fdb6139-394b-1510-4baf-bde68c419789	Product name	1	20140508
aef26912-037b-9a4e-db49-225ef6dfd8f1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0327-56	fluticasone propionate and salmeterol	1 in 1 POUCH	POWDER	1		7
0054-0327-56	fluticasone propionate and salmeterol	1 in 1 CARTON	POWDER	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0327-56	EA - Each	0054-0327	31f5ea9f-b162-4890-9499-ea74af565578	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0327	FLUTICASONE PROPIONATE AND SALMETEROL POWDER [HIKMA PHARMACEUTICALS USA INC.]	7	Current NDC, Legacy NDC, 2 package rows	20241207_f9fcfc90-3677-4a9b-900e-44417d50d507.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fluticasone propionate and salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	REMEDYREPACK INC.	7fecae39-f966-4da5-99f6-4d9428d1b147	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203433 application number: ANDA203433
fluticasone propionate and salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	REMEDYREPACK INC.	7fdaa6db-82bd-4941-be11-ee80a0784d55	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203433 application number: ANDA203433
fluticasone propionate and salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	Preferred Pharmaceuticals Inc.	0dea4818-e9d6-42f2-a702-90419fff2695	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203433 application number: ANDA203433
fluticasone propionate and salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	Preferred Pharmaceuticals Inc.	08870f40-8c46-4d91-a101-c3cbb894ca49	2025-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203433 application number: ANDA203433
fluticasone propionate and salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	Hikma Pharmaceuticals USA Inc.	f9fcfc90-3677-4a9b-900e-44417d50d507	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203433 application number: ANDA203433 ndc (product): 0054-0327

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O2GMZ0LF5W	FLUTICASONE PROPIONATE	80474-14-2	FLUTICASONE PROPIONATE
6EW8Q962A5	SALMETEROL XINAFOATE	94749-08-3	SALMETEROL XINAFOATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896184	fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896209	fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896228	fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896184	60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler	SCD	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896209	60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler	SCD	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896228	60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler	SCD	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896184	fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896209	fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896228	fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896184	fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896209	fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896228	fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	f9fcfc90-3677-4a9b-900e-44417d50d507	7
896209	fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	7fecae39-f966-4da5-99f6-4d9428d1b147	5
896209	60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler	SCD	7fecae39-f966-4da5-99f6-4d9428d1b147	5
896209	fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	7fecae39-f966-4da5-99f6-4d9428d1b147	5
896209	fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	7fecae39-f966-4da5-99f6-4d9428d1b147	5
896209	fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	0dea4818-e9d6-42f2-a702-90419fff2695	3
896209	60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler	SCD	0dea4818-e9d6-42f2-a702-90419fff2695	3
896209	fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	0dea4818-e9d6-42f2-a702-90419fff2695	3
896209	fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	0dea4818-e9d6-42f2-a702-90419fff2695	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0327-56	00054032756	1 POUCH in 1 CARTON (0054-0327-56) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER	1 pouch	2020-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
fluticasone propionate and salmeterol - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-06-11	HUMAN PRESCRIPTION DRUG LABEL	6
fluticasone propionate and salmeterol - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2025-05-16	HUMAN PRESCRIPTION DRUG LABEL	3
SALMETEROL XINAFOATE - Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2024-12-05	HUMAN PRESCRIPTION DRUG LABEL	7