Fluticasone Propionate and Salmeterol HFA

Product NDC: 66993-087
11-digit product format: 669930087
Labeler code: 66993
Product ID: 66993-087_7a85b8b8-7336-4563-9cf7-a03693e08f70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluticasone propionate and salmeterol xinafoate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Prasco Laboratories
Application: NDA021254
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2023-03-01
Substance: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength: 115; 21 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021254-001	ADVAIR HFA	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08
N021254-002	ADVAIR HFA	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08
N021254-003	ADVAIR HFA	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021254-002	ADVAIR HFA	0.115MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021254-003	ADVAIR HFA	0.23MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021254-001	ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2006-06-08	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 326 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-001	7832351	2023-06-19	Drug product	2012-09-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-001	7832351*PED	2023-12-19	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-001	7500444	2026-02-26	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-001	7500444*PED	2026-08-26	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-002	7832351	2023-06-19	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-002	7832351*PED	2023-12-19	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-002	7500444	2026-02-26	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-002	7500444*PED	2026-08-26	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-003	7832351	2023-06-19	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-003	7832351*PED	2023-12-19	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-003	7500444	2026-02-26	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021254-003	7500444*PED	2026-08-26	Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021254-001	7832351	2023-06-19	Drug product	2012-09-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021254-001	7832351*PED	2023-12-19	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021254-001	7500444	2026-02-26	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021254-001	7500444*PED	2026-08-26	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021254-002	7832351	2023-06-19	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021254-002	7832351*PED	2023-12-19	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021254-002	7500444	2026-02-26	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021254-002	7500444*PED	2026-08-26	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021254-003	7832351	2023-06-19	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021254-003	7832351*PED	2023-12-19	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021254-003	7500444	2026-02-26	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021254-003	7500444*PED	2026-08-26	Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021254-001	7832351	2023-06-19	Drug product	2012-09-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021254-001	7832351*PED	2023-12-19	Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021254-001	7500444	2026-02-26	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021254-001	7500444*PED	2026-08-26	Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021254-002	7832351	2023-06-19	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021254-002	7832351*PED	2023-12-19	Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021254-002	7500444	2026-02-26	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021254-002	7500444*PED	2026-08-26	Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021254-003	7832351	2023-06-19	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021254-003	7832351*PED	2023-12-19	Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021254-003	7500444	2026-02-26	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021254-003	7500444*PED	2026-08-26	Pediatric extension		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021254-001	7350676*PED	2019-02-24	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021254-001	9861771	2020-10-11	Drug product	2018-03-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021254-001	7832351	2023-06-19	Drug product	2012-09-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021254-001	7832351*PED	2023-12-19	Pediatric extension		`74a2ff9319b5…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUTICASONE PROPIONATE	115 ug/1
SALMETEROL XINAFOATE	21 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
896236	Internal RxNorm lookup
896244	Internal RxNorm lookup
896272	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
666c5b12-a4f7-4c53-8261-4742b5e5a6df	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
66993-087-96	Fluticasone Propionate and Salmeterol HFA	1 in 1 CARTON	AEROSOL, METERED	1		5
66993-087-96	Fluticasone Propionate and Salmeterol HFA	120 in 1 INHALER	AEROSOL, METERED	120		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-087-96	GM - Gram	66993-087	79794445-c2ae-4b7a-b98c-99544e531df7	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-087	FLUTICASONE PROPIONATE AND SALMETEROL HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE) AEROSOL, METERED [PRASCO LABORATORIES]	4	Current NDC, 2 package rows	20250525_666c5b12-a4f7-4c53-8261-4742b5e5a6df.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADVAIR HFA	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	A-S Medication Solutions	80b36523-4ae4-463e-b1fd-b929fb802b76	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021254 application number: NDA021254
ADVAIR HFA	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	A-S Medication Solutions	223fd5d4-3bd2-4e45-b72e-699438c32206	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021254 application number: NDA021254
Fluticasone Propionate and Salmeterol HFA	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	Prasco Laboratories	666c5b12-a4f7-4c53-8261-4742b5e5a6df	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021254 application number: NDA021254 ndc (product): 66993-087
ADVAIR HFA	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	GlaxoSmithKline LLC	dfaca6f9-3277-47b2-319d-1377917cb54c	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021254 application number: NDA021254

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
896244	fluticasone propionate/salmeterol 115/21 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5
896272	fluticasone propionate/salmeterol 230/21 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5
896236	fluticasone propionate/salmeterol 45/21 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5
896236	120 ACTUAT fluticasone propionate 0.045 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler	SCD	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5
896244	120 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler	SCD	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5
896272	120 ACTUAT fluticasone propionate 0.23 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler	SCD	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5
896236	fluticasone propionate 0.045 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5
896244	fluticasone propionate 0.115 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5
896272	fluticasone propionate 0.23 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5
896244	fluticasone propionate 115 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5
896272	fluticasone propionate 230 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5
896236	fluticasone propionate 45 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	666c5b12-a4f7-4c53-8261-4742b5e5a6df	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
66993-087-96	66993008796	1 INHALER in 1 CARTON (66993-087-96) / 120 AEROSOL, METERED in 1 INHALER	1 inhaler	2023-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUTICASONE PROPIONATE - Prasco Laboratories \| GlaxoSmithKline LLC	Prasco Laboratories \| GlaxoSmithKline LLC	2024-05-29	HUMAN PRESCRIPTION DRUG LABEL	5