FDA.reportPublic FDA data

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE

Product NDC
63629-8612
Requested package NDC
63629-8612-1
11-digit product format
636298612
Labeler code
63629
Product ID
63629-8612_2cb5fed9-e2fc-448c-87df-83af32f6bc78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azelastine hydrochloride, fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Bryant Ranch Prepack
Application
ANDA208111
Marketing category
ANDA
Marketing start
2021-03-01
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
A208111-001AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEAZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE0.137MG/SPRAY;0.05MG/SPRAYSPRAY, METERED / NASALAB2021-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208111-001AB

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
2026-08-01 22:54:322026-06A208111-001AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE0.137MG/SPRAY;0.05MG/SPRAYSPRAY, METERED / NASALAB2021-02-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208111-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEAZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATEBryant Ranch Prepacke95227ff-5747-4a35-a1b8-b1019fe1e61c2025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208111
application number: ANDA208111
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEAZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATEBryant Ranch Prepack1a930a09-db26-40aa-bb05-123a0d7182bc2025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208111
application number: ANDA208111
ndc (package): 63629-8612-1
ndc (product): 63629-8612
ndc11 (package): 63629861201
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEAZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATEPadagis Israel Pharmaceuticals Ltd625ffdd0-8486-49af-8e77-6aa663be5ac72025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208111
application number: ANDA208111

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
1a930a09-db26-40aa-bb05-123a0d7182bcAvailable 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
63629-8612-1AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE120 in 1 BOTTLESPRAY, METERED120104
63629-8612-1AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE1 in 1 CARTONSPRAY, METERED1104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8612-1GM - Gram63629-8612fa5ca6a6-b02a-4aec-b4b9-53cce0e6eee512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8612AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE) SPRAY, METERED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20250330_1a930a09-db26-40aa-bb05-123a0d7182bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797847azelastine HCl 137 MCG/ACTUAT / fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN1a930a09-db26-40aa-bb05-123a0d7182bc104
1797847azelastine hydrochloride 0.137 MG/ACTUAT / fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD1a930a09-db26-40aa-bb05-123a0d7182bc104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8612-1636298612011 BOTTLE in 1 CARTON (63629-8612-1) / 120 SPRAY, METERED in 1 BOTTLE1 bottle2021-03-010000-00-00NoNoCurrent