FDA.reportPublic FDA data

Azelastine Hydrochloride and Fluticasone Propionate

Product NDC
0480-2157
11-digit product format
004802157
Labeler code
0480
Product ID
0480-2157_edea3e4b-7afc-4566-864d-acdf480a92af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azelastine Hydrochloride and Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA208436
Marketing category
ANDA
Marketing start
2025-09-08
Substance
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Active strength
137; 50 ug/1; ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208436-001AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEAZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE0.137MG/SPRAY;0.05MG/SPRAYSPRAY, METERED / NASALAB2025-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208436-001AB

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
2026-02-19 14:30 UTC2026-02A208436-001AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE0.137MG/SPRAY;0.05MG/SPRAYSPRAY, METERED / NASALAB2025-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208436-001AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE0.137MG/SPRAY;0.05MG/SPRAYSPRAY, METERED / NASALAB2025-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A208436-001AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE0.137MG/SPRAY;0.05MG/SPRAYSPRAY, METERED / NASALAB2025-04-086a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208436-001AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE0.137MG/SPRAY;0.05MG/SPRAYSPRAY, METERED / NASALAB2025-04-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208436-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208436-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208436-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208436-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Azelastine Hydrochloride and Fluticasone Propionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZELASTINE HYDROCHLORIDE137 ug/1
FLUTICASONE PROPIONATE50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0L591QR10IInternal UNII lookup
O2GMZ0LF5WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1797847Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d45e7a4-900f-44ef-bb18-a1fbff75a3c6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
85ee67c3-6973-4172-9ada-b124d28b42f8Product name520210528
6397aa5d-11e2-42ce-b46f-ac49599ccf00Product name520201006
033d5d5b-187f-1f40-1e5a-11d732813f92Product name420200626
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-2157-57Azelastine Hydrochloride and Fluticasone Propionate120 in 1 BOTTLE, SPRAYSPRAY, METERED1202
0480-2157-57Azelastine Hydrochloride and Fluticasone Propionate1 in 1 CARTONSPRAY, METERED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-2157-57GM - Gram0480-215755a23b91-d40c-4056-9bbc-a5fb13326a7512025-10-14

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
Azelastine Hydrochloride and Fluticasone PropionateAZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATETeva Pharmaceuticals, Inc.0d45e7a4-900f-44ef-bb18-a1fbff75a3c62025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208436
application number: ANDA208436
ndc (product): 0480-2157

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797847azelastine HCl 137 MCG/ACTUAT / fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN0d45e7a4-900f-44ef-bb18-a1fbff75a3c62
1797847azelastine hydrochloride 0.137 MG/ACTUAT / fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD0d45e7a4-900f-44ef-bb18-a1fbff75a3c62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-2157-57004802157571 BOTTLE, SPRAY in 1 CARTON (0480-2157-57) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2025-09-08NoNoCurrent