Home NDC 50090-6590 Budesonide
Product NDC 50090-6590
11-digit product format 500906590
Labeler code 50090
Product ID 50090-6590_603b6f9a-a2ea-46b1-9ed1-c5fa6cb97507
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Budesonide
Dosage form SUSPENSION
Route RESPIRATORY (INHALATION)
Labeler A-S Medication Solutions
Application ANDA211922
Marketing category ANDA
Marketing start 2021-05-01
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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211922-001 BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 A211922-002 BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 A211922-003 BUDESONIDE BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211922-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2021-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211922-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2021-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211922-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2021-04-14 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 102 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Budesonide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUDESONIDE .25 mg/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q3OKS62Q6X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349094 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-6590-0 Budesonide 6 in 1 CARTON SUSPENSION 6 6 50090-6590-0 Budesonide 5 in 1 POUCH SUSPENSION 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6590 BUDESONIDE SUSPENSION [A-S MEDICATION SOLUTIONS] 6 Current NDC, 2 package rows 20250223_d406759d-4c02-4fc0-b513-56b303afca98.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-6590-0 50090659000 6 POUCH in 1 CARTON (50090-6590-0) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE 6 pouch 2023-08-14 No No Current