Alvesco

Product NDC
70515-711
11-digit product format
705150711
Labeler code
70515
Product ID
70515-711_3a8b4338-890b-bc2f-e063-6394a90ab578
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciclesonide
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Covis Pharma US, Inc
Application
NDA021658
Marketing category
NDA
Marketing start
2018-03-26
Substance
CICLESONIDE
Active strength
80 ug/1
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021658-002ALVESCOCICLESONIDE0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10
N021658-003ALVESCOCICLESONIDE0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021658-00283712922028-02-01U-1355
N021658-00383712922028-02-01U-1355

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-1084e616aacf4f…
2026-09-14 22:38:342026-08N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-1084e616aacf4f…
2026-08-18 06:07:402026-07N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021658-002ALVESCO0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021658-003ALVESCO0.16MG/INHAEROSOL, METERED / INHALATIONRLD, RS2008-01-1074a2ff9319b5…

Observed Orange Book patent history#

Patent history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N021658-00283712922028-02-01U-135584e616aacf4f…
2026-09-14 22:38:342026-08N021658-00383712922028-02-01U-135584e616aacf4f…
2026-08-18 06:07:402026-07N021658-00283712922028-02-01U-1355caaa826d4ba7…
2026-08-18 06:07:402026-07N021658-00383712922028-02-01U-1355caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021658-00283712922028-02-01U-1355011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021658-00383712922028-02-01U-1355011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021658-00283712922028-02-01U-135531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021658-00383712922028-02-01U-135531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021658-00283712922028-02-01U-13556a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021658-00383712922028-02-01U-13556a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021658-00283712922028-02-01U-1355fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021658-00383712922028-02-01U-1355fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021658-00283712922028-02-01U-1355b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021658-00383712922028-02-01U-1355b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021658-00283712922028-02-01U-135503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021658-00383712922028-02-01U-135503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021658-00283712922028-02-01U-13552680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021658-00383712922028-02-01U-13552680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021658-00283712922028-02-01U-13555bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021658-00383712922028-02-01U-13555bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021658-00283712922028-02-01U-1355d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021658-00383712922028-02-01U-1355d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021658-00283712922028-02-01U-1355d06236e962d9…
2024-10-29 15:01 UTC2024-10N021658-00383712922028-02-01U-1355d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021658-00283712922028-02-01U-135579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021658-00383712922028-02-01U-135579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021658-00283712922028-02-01U-1355301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021658-00383712922028-02-01U-1355301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021658-00283712922028-02-01U-13551e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021658-00383712922028-02-01U-13551e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021658-00283712922028-02-01U-13558072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021658-00383712922028-02-01U-13558072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021658-00283712922028-02-01U-13555c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021658-00383712922028-02-01U-13555c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021658-00283712922028-02-01U-13555d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021658-00383712922028-02-01U-13555d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021658-00283712922028-02-01U-13554b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021658-00383712922028-02-01U-13554b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021658-00283712922028-02-01U-135574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021658-00383712922028-02-01U-135574a2ff9319b5…

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
Alvesco
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CICLESONIDE80 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S59502J185Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
799034Internal RxNorm lookup
799037Internal RxNorm lookup
799038Internal RxNorm lookup
799040Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f6112fb-78ef-43cf-8ae3-36370eb45468Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0744342f-aac4-801e-ee21-395ccd0c8e83Product name120140508
85b616d1-2593-be25-fa48-8e59fa292b7bProduct name120140508
c2c67206-646a-760e-80fc-8113bd89fd45Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70515-711-01Alvesco60 in 1 INHALERAEROSOL, METERED608
70515-711-01Alvesco1 in 1 CARTONAEROSOL, METERED18
70515-711-02Alvesco1 in 1 CARTONAEROSOL, METERED18
70515-711-02Alvesco60 in 1 INHALERAEROSOL, METERED608
70515-711-03Alvesco30 in 1 INHALERAEROSOL, METERED308
70515-711-03Alvesco1 in 1 CARTONAEROSOL, METERED18
70515-711-04Alvesco1 in 1 CARTONAEROSOL, METERED18
70515-711-04Alvesco30 in 1 INHALERAEROSOL, METERED308
70515-711-05Alvesco1 in 1 CARTONAEROSOL, METERED18
70515-711-05Alvesco60 in 1 INHALERAEROSOL, METERED608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70515-711-01GM - Gram70515-711da0480f7-c54a-4695-88ba-f9bcc0fa17a512018-07-03
70515-711-05GM - Gram70515-7117041ded7-9867-4171-b833-c6f9892d57b912021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70515-711ALVESCO (CICLESONIDE) AEROSOL, METERED [COVIS PHARMA US, INC]7Current NDC, Legacy NDC, 10 package rows20230301_9f6112fb-78ef-43cf-8ae3-36370eb45468.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlvescoCICLESONIDECovis Pharma US, Inc9f6112fb-78ef-43cf-8ae3-36370eb454682025-02-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 021658
application number: NDA021658
ndc (product): 70515-711

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
799037Alvesco 160 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN9f6112fb-78ef-43cf-8ae3-36370eb454688
799040Alvesco 80 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN9f6112fb-78ef-43cf-8ae3-36370eb454688
799034ciclesonide 160 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN9f6112fb-78ef-43cf-8ae3-36370eb454688
799038ciclesonide 80 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN9f6112fb-78ef-43cf-8ae3-36370eb454688
79904060 ACTUAT ciclesonide 0.08 MG/ACTUAT Metered Dose Inhaler [Alvesco]SBD9f6112fb-78ef-43cf-8ae3-36370eb454688
79903760 ACTUAT ciclesonide 0.16 MG/ACTUAT Metered Dose Inhaler [Alvesco]SBD9f6112fb-78ef-43cf-8ae3-36370eb454688
79903860 ACTUAT ciclesonide 0.08 MG/ACTUAT Metered Dose InhalerSCD9f6112fb-78ef-43cf-8ae3-36370eb454688
79903460 ACTUAT ciclesonide 0.16 MG/ACTUAT Metered Dose InhalerSCD9f6112fb-78ef-43cf-8ae3-36370eb454688
79904060 ACTUAT Alvesco 0.08 MG/ACTUAT Metered Dose InhalerSY9f6112fb-78ef-43cf-8ae3-36370eb454688
79903760 ACTUAT Alvesco 0.16 MG/ACTUAT Metered Dose InhalerSY9f6112fb-78ef-43cf-8ae3-36370eb454688
799040Alvesco 0.08 MG/ACTUAT Metered Dose Inhaler, 60 ACTUATSY9f6112fb-78ef-43cf-8ae3-36370eb454688
799037Alvesco 0.16 MG/ACTUAT Metered Dose Inhaler, 60 ACTUATSY9f6112fb-78ef-43cf-8ae3-36370eb454688
799037Alvesco 160 MCG/ACTUAT Metered Dose Inhaler, 60 ACTUATSY9f6112fb-78ef-43cf-8ae3-36370eb454688
799040Alvesco 80 MCG/ACTUAT Metered Dose Inhaler, 60 ACTUATSY9f6112fb-78ef-43cf-8ae3-36370eb454688
799038ciclesonide 0.08 MG/ACTUAT Metered Dose Inhaler, 60 ACTUATSY9f6112fb-78ef-43cf-8ae3-36370eb454688
799034ciclesonide 160 MCG/ACTUAT Metered Dose Inhaler, 60 ACTUATSY9f6112fb-78ef-43cf-8ae3-36370eb454688
799038ciclesonide 80 MCG/ACTUAT Metered Dose Inhaler, 60 ACTUATSY9f6112fb-78ef-43cf-8ae3-36370eb454688

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70515-711-01705150711011 INHALER in 1 CARTON (70515-711-01) / 60 AEROSOL, METERED in 1 INHALER1 inhaler2018-03-260000-00-00NoNoCurrent
70515-711-02705150711021 INHALER in 1 CARTON (70515-711-02) / 60 AEROSOL, METERED in 1 INHALER1 inhaler2018-03-260000-00-00YesNoCurrent
70515-711-03705150711031 INHALER in 1 CARTON (70515-711-03) / 30 AEROSOL, METERED in 1 INHALER1 inhaler2021-04-300000-00-00NoNoCurrent
70515-711-04705150711041 INHALER in 1 CARTON (70515-711-04) / 30 AEROSOL, METERED in 1 INHALER1 inhaler2021-04-300000-00-00NoNoCurrent
70515-711-05705150711051 INHALER in 1 CARTON (70515-711-05) / 60 AEROSOL, METERED in 1 INHALER1 inhaler2021-04-300000-00-00NoNoCurrent