Budesonide

Product NDC
76282-640
11-digit product format
762820640
Labeler code
76282
Product ID
76282-640_c53a81a4-fad8-4587-ac13-cc4de968485e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
INHALANT
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA205710
Marketing category
ANDA
Marketing start
2019-04-17
Substance
BUDESONIDE
Active strength
.25 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205710-001BUDESONIDEBUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-16
A205710-002BUDESONIDEBUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-16
A205710-003BUDESONIDEBUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A205710-001AN
A205710-002AN
A205710-003AN

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205710-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2017-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205710-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2017-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205710-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2017-11-168072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205710-001AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205710-002AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205710-003AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205710-001AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205710-002AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205710-003AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205710-001AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205710-002AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205710-003AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205710-001AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205710-002AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205710-003AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205710-001AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205710-002AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205710-003AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205710-001AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205710-002AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205710-003AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205710-001AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205710-002AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205710-003AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205710-001AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205710-002AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205710-003AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205710-001AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205710-002AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205710-003AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205710-001AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205710-002AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205710-003AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205710-001AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205710-002AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205710-003AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205710-001AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205710-002AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205710-003AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205710-001AN11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205710-002AN11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205710-003AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205710-001AN18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE.25 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
252559Internal RxNorm lookup
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
d9656442-4587-4867-9a8c-5f5b0402936eAvailable 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
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-640-37BudesonideInhalation Suspension5 in 1 POUCHINHALANT54
76282-640-37BudesonideInhalation Suspension2 mL in 1 AMPULEINHALANT24
76282-640-38BudesonideInhalation Suspension6 in 1 CARTONINHALANT64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-640-37ML - Milliliter76282-640b5dfd5a8-054f-43f6-83b1-4543128c7e7212019-05-02
76282-640-38ML - Milliliter76282-6405f910817-c6eb-4a56-926c-0c08c3505dd612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-640BUDESONIDE INHALATION SUSPENSION (BUDESONIDE) INHALANT [EXELAN PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20201212_d9656442-4587-4867-9a8c-5f5b0402936e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Budesonide Inhalation SuspensionBUDESONIDECipla USA Inc.c52c5382-1400-44b9-95be-a30e1cf706da2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205710
application number: ANDA205710
Budesonide Inhalation SuspensionBUDESONIDEPreferred Pharmaceuticals Inc.dcb35488-23c5-4e7b-ab86-8406cf8557482025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205710
application number: ANDA205710
Budesonide Inhalation SuspensionBUDESONIDEExelan Pharmaceuticals, Inc.d9656442-4587-4867-9a8c-5f5b0402936e2020-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205710
application number: ANDA205710
ndc (product): 76282-640

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSNd9656442-4587-4867-9a8c-5f5b0402936e4
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSNd9656442-4587-4867-9a8c-5f5b0402936e4
252559budesonide 1 MG in 2 ML Inhalation SuspensionPSNd9656442-4587-4867-9a8c-5f5b0402936e4
349094budesonide 0.125 MG/ML Inhalation SuspensionSCDd9656442-4587-4867-9a8c-5f5b0402936e4
351109budesonide 0.25 MG/ML Inhalation SuspensionSCDd9656442-4587-4867-9a8c-5f5b0402936e4
252559budesonide 0.5 MG/ML Inhalation SuspensionSCDd9656442-4587-4867-9a8c-5f5b0402936e4
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSYd9656442-4587-4867-9a8c-5f5b0402936e4
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSYd9656442-4587-4867-9a8c-5f5b0402936e4
252559budesonide 1 MG per 2 ML Inhalation SuspensionSYd9656442-4587-4867-9a8c-5f5b0402936e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-640-37762820640375 in 1 POUCHHistorical
76282-640-38762820640386 POUCH in 1 CARTON (76282-640-38) / 5 AMPULE in 1 POUCH (76282-640-37) / 2 mL in 1 AMPULE6 pouch2019-04-170000-00-00NoNoCurrent