Home NDC 68258-8922 Budesonide
Product NDC 68258-8922
11-digit product format 682588922
Labeler code 68258
Product ID 68258-8922_478e24f9-c2b6-4b8e-bfff-73f19b671e86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Budesonide
Dosage form SUSPENSION
Route RESPIRATORY (INHALATION)
Labeler Dispensing Solutions, Inc.
Application ANDA077519
Marketing category ANDA
Marketing start 2008-11-19
Marketing end 0000-00-00
Substance BUDESONIDE
Active strength 1 mg/2mL
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68258-8922-5 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68258-8922-5 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68258-8922-5 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68258-8922-5 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68258-8922-5 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68258-8922-5 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68258-8922-5 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68258-8922-5 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68258-8922-5 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68258-8922-5 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68258-8922-5 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68258-8922-5 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68258-8922-5 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68258-8922-5 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68258-8922-5 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68258-8922-5 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68258-8922-5 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68258-8922-5 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68258-8922-5 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68258-8922-5 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68258-8922-5 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68258-8922-5 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077519-001 BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 A077519-002 BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 84 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 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077519-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2008-11-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077519-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2008-11-18 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68258-8922-5 Budesonide 2 mL in 1 VIAL, SINGLE-DOSE SUSPENSION 2 1 68258-8922-5 Budesonide 5 in 1 POUCH SUSPENSION 5 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUDESONIDE ACTIVE INGREDIENT Q3OKS62Q6X BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] 1 BUDESONIDE ACTIVE MOIETY Q3OKS62Q6X BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68258-8922 BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] 1 Legacy NDC, 2 package rows 20130831_78d25104-15c6-499c-a748-b3407cd9738e.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 Status 68258-8922-5 68258892205 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical