Budesonide

Product NDC
60687-889
11-digit product format
606870889
Labeler code
60687
Product ID
60687-889_52188517-5a8c-b7e4-e063-6394a90af76b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
American Health Packaging
Application
ANDA211922
Marketing category
ANDA
Marketing start
2026-05-15
Substance
BUDESONIDE
Active strength
.25 mg/2mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211922-001BUDESONIDEBUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-14
A211922-002BUDESONIDEBUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-14
A211922-003BUDESONIDEBUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211922-001AN
A211922-002AN
A211922-003AN

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 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211922-002BUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONAN2021-04-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211922-003BUDESONIDE1MG/2MLSUSPENSION / INHALATIONAN2021-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211922-001BUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONAN2021-04-141e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211922-001AN1caaa826d4ba7…
2026-08-18 06:07:402026-07A211922-002AN1caaa826d4ba7…
2026-08-18 06:07:402026-07A211922-003AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211922-001AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211922-002AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211922-003AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211922-001AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211922-002AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211922-003AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211922-001AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211922-002AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211922-003AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211922-001AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211922-002AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211922-003AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211922-001AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211922-002AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211922-003AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211922-001AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211922-002AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211922-003AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211922-001AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211922-002AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211922-003AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211922-001AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211922-002AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211922-003AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211922-001AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211922-002AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211922-003AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211922-001AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211922-002AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211922-003AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211922-001AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211922-002AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211922-003AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211922-001AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211922-002AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211922-003AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211922-001AN11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Budesonide
Listing expiration
2027-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7df2a10-4166-423e-bb60-5f3a8234f26cAvailable 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
60687-889-79Budesonide1 in 1 POUCHSUSPENSION13
60687-889-79Budesonide2 mL in 1 AMPULESUSPENSION23
60687-889-83Budesonide30 in 1 CARTONSUSPENSION303

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BudesonideBUDESONIDEAmerican Health Packagingc7df2a10-4166-423e-bb60-5f3a8234f26c2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211922
application number: ANDA211922
ndc (product): 60687-889
BudesonideBUDESONIDESun Pharmaceutical Industries, Inc.a39fbcfc-3ffd-44bd-b882-01f8e18442132026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211922
application number: ANDA211922
BudesonideBUDESONIDEA-S Medication Solutionsd406759d-4c02-4fc0-b513-56b303afca982025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211922
application number: ANDA211922
BudesonideBUDESONIDEA-S Medication Solutions4a7d97e0-36f7-4ac9-8f9b-4c3aac568c2b2023-09-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211922
application number: ANDA211922

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSNc7df2a10-4166-423e-bb60-5f3a8234f26c3
349094budesonide 0.125 MG/ML Inhalation SuspensionSCDc7df2a10-4166-423e-bb60-5f3a8234f26c3
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSYc7df2a10-4166-423e-bb60-5f3a8234f26c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-889-79606870889791 in 1 POUCHHistorical
60687-889-836068708898330 POUCH in 1 CARTON (60687-889-83) / 1 AMPULE in 1 POUCH (60687-889-79) / 2 mL in 1 AMPULE30 pouch2026-05-15NoNoCurrent