FDA.reportPublic FDA data

Beclomethasone Dipropionate

Product NDC
69238-1289
11-digit product format
692381289
Labeler code
69238
Product ID
69238-1289_e351b5e4-d97c-4b2b-8d12-ca34987d2b88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Beclomethasone Dipropionate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA213811
Marketing category
ANDA
Marketing start
2025-12-17
Substance
BECLOMETHASONE DIPROPIONATE
Active strength
40 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213811-001BECLOMETHASONE DIPROPIONATEBECLOMETHASONE DIPROPIONATE0.04MG/INHAEROSOL, METERED / INHALATIONRS2025-12-16
A213811-002BECLOMETHASONE DIPROPIONATEBECLOMETHASONE DIPROPIONATE0.08MG/INHAEROSOL, METERED / INHALATIONRS2025-12-16

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 UTC2026-02A213811-001BECLOMETHASONE DIPROPIONATE0.04MG/INHAEROSOL, METERED / INHALATIONRS2025-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213811-002BECLOMETHASONE DIPROPIONATE0.08MG/INHAEROSOL, METERED / INHALATIONRS2025-12-16011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213811-001BECLOMETHASONE DIPROPIONATE0.04MG/INHAEROSOL, METERED / INHALATIONRS2025-12-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213811-002BECLOMETHASONE DIPROPIONATE0.08MG/INHAEROSOL, METERED / INHALATIONRS2025-12-16a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Beclomethasone Dipropionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BECLOMETHASONE DIPROPIONATE40 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5B307S63B2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1490666Internal RxNorm lookup
1490773Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d853c96f-21a3-4def-931d-4d47d16acd62Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
56560def-9e4f-4cea-995d-33e9e282a050Product name120171204
7cc1653a-dc36-45c2-8752-61a7a3967d75Product name120170829
e97c5025-cafa-043f-50a3-771ab2b84660Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1289-4Beclomethasone Dipropionate1 in 1 CARTONAEROSOL, METERED112
69238-1289-4Beclomethasone Dipropionate120 in 1 CANISTERAEROSOL, METERED12012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1289-4GM - Gram69238-12895c07b931-0180-4536-9302-d4bfb408d78412026-04-20

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
Beclomethasone DipropionateBECLOMETHASONE DIPROPIONATEAmneal Pharmaceuticals NY LLCd853c96f-21a3-4def-931d-4d47d16acd622020-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213811
application number: ANDA213811
ndc (product): 69238-1289

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490773beclomethasone dipropionate 40 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNd853c96f-21a3-4def-931d-4d47d16acd6212
1490666beclomethasone dipropionate 80 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNd853c96f-21a3-4def-931d-4d47d16acd6212
1490773120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose InhalerSCDd853c96f-21a3-4def-931d-4d47d16acd6212
1490666120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose InhalerSCDd853c96f-21a3-4def-931d-4d47d16acd6212
1490773beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose Inhaler, 120 ACTUATSSYd853c96f-21a3-4def-931d-4d47d16acd6212
1490666beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler, 120 ACTUATSSYd853c96f-21a3-4def-931d-4d47d16acd6212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-1289-4692381289041 CANISTER in 1 CARTON (69238-1289-4) / 120 AEROSOL, METERED in 1 CANISTER1 canister2025-12-17NoNoCurrent