FDA.reportPublic FDA data

Budesonide

Product NDC
62135-823
Requested package NDC
62135-823-84
11-digit product format
621350823
Labeler code
62135
Product ID
62135-823_10690463-7fb3-af77-e063-6294a90ad2de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
Chartwell RX, LLC
Application
ANDA078202
Marketing category
ANDA
Marketing start
2013-10-01
Substance
BUDESONIDE
Active strength
.5 mg/2mL
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
A078202-001BUDESONIDEBUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2009-03-30
A078202-002BUDESONIDEBUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2009-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078202-001AN
A078202-002AN

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 22:54:322026-06A078202-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2009-03-30a50c72e98297…
2026-08-01 22:54:322026-06A078202-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2009-03-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078202-001AN1a50c72e98297…
2026-08-01 22:54:322026-06A078202-002AN1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BudesonideBUDESONIDERising Pharma Holdings, Inc.3235e2a4-8e12-2d58-e063-6294a90a49362026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078202
application number: ANDA078202
BudesonideBUDESONIDENephron Pharmaceuticals Corporationf12043df-f9a3-4edb-88f8-dd176c1a141c2025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078202
application number: ANDA078202
BudesonideBUDESONIDEA-S Medication Solutions521a79d0-4d93-45f7-8feb-8d2b502dd2162024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078202
application number: ANDA078202
BudesonideBUDESONIDEChartwell RX, LLC374013c9-18c9-4419-b9fb-9bc5c765688e2024-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078202
application number: ANDA078202
ndc (package): 62135-823-84
ndc (product): 62135-823
ndc11 (package): 62135082384

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE.5 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q3OKS62Q6XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349094Internal RxNorm lookup
351109Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
374013c9-18c9-4419-b9fb-9bc5c765688eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7816cdf6-b925-4282-bedd-11ae25d518a1Product name120250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4dProduct name220240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
54a29484-7dde-4771-9547-005149321621Product name120220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743Product name520211018
218c043e-94e5-4e66-a363-d0d446485bc6Product name220210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7Product name920210127
da63bc8c-2e89-4044-89d6-1facbff5474eProduct name120200121
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-823-84Budesonide6 in 1 CARTONSUSPENSION61
62135-823-84Budesonide5 in 1 POUCHSUSPENSION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-823-84ML - Milliliter62135-823fc737b83-6ceb-460c-b686-ebc76203d73c12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-823BUDESONIDE SUSPENSION [CHARTWELL RX, LLC]1Current NDC, 2 package rows20240203_374013c9-18c9-4419-b9fb-9bc5c765688e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSN374013c9-18c9-4419-b9fb-9bc5c765688e1
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSN374013c9-18c9-4419-b9fb-9bc5c765688e1
349094budesonide 0.125 MG/ML Inhalation SuspensionSCD374013c9-18c9-4419-b9fb-9bc5c765688e1
351109budesonide 0.25 MG/ML Inhalation SuspensionSCD374013c9-18c9-4419-b9fb-9bc5c765688e1
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSY374013c9-18c9-4419-b9fb-9bc5c765688e1
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSY374013c9-18c9-4419-b9fb-9bc5c765688e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-823-84621350823846 POUCH in 1 CARTON (62135-823-84) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE6 pouch2024-01-30NoNoCurrent