FLUTICASONE PROPIONATE

Product NDC: 68071-3949
Requested package NDC: 68071-3949-5
11-digit product format: 680713949
Labeler code: 68071
Product ID: 68071-3949_4849c4ec-c391-912e-e063-6394a90a1c24
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FLUTICASONE PROPIONATE
Dosage form: SPRAY
Route: NASAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA218321
Marketing category: ANDA
Marketing start: 2025-06-05
Substance: FLUTICASONE PROPIONATE
Active strength: 50 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218321-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB		2025-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218321-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218321-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2025-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218321-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2025-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218321-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2025-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218321-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2025-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218321-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2025-06-05	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218321-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2025-06-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218321-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218321-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218321-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218321-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218321-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218321-001	AB	1	`a50c72e98297…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUTICASONE PROPIONATE	50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O2GMZ0LF5W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1797907	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
4849c4e5-58ea-972c-e063-6394a90a809c	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
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3949-5	FLUTICASONE PROPIONATE	1 in 1 CARTON	SPRAY	1		1
68071-3949-5	FLUTICASONE PROPIONATE	120 in 1 BOTTLE, SPRAY	SPRAY	120		1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Preferred Pharmaceuticals Inc.	8225d521-f1f7-4d21-9095-9a2e1833d1bf	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218321 application number: ANDA218321
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Advagen Pharma Ltd	2c1c465c-d008-470e-aa48-8b44bd60751c	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218321 application number: ANDA218321
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	NuCare Pharmaceuticals, Inc.	4849c4e5-58ea-972c-e063-6394a90a809c	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218321 application number: ANDA218321 ndc (package): 68071-3949-5 ndc (product): 68071-3949 ndc11 (package): 68071394905

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O2GMZ0LF5W	FLUTICASONE PROPIONATE	80474-14-2	FLUTICASONE PROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	PSN	4849c4e5-58ea-972c-e063-6394a90a809c	1
1797907	fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray	SCD	4849c4e5-58ea-972c-e063-6394a90a809c	1
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	SY	4849c4e5-58ea-972c-e063-6394a90a809c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3949-5	68071394905	1 BOTTLE, SPRAY in 1 CARTON (68071-3949-5) / 120 SPRAY in 1 BOTTLE, SPRAY	2026-01-13	No	No	Current