Home NDC 68788-8429 Budesonide Inhalation
Product NDC 68788-8429
11-digit product format 687888429
Labeler code 68788
Product ID 68788-8429_0804e044-4488-4f33-a34a-2a5be982cc7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Budesonide
Dosage form SUSPENSION
Route RESPIRATORY (INHALATION)
Labeler Preferred Pharmaceuticals Inc.
Application ANDA078404
Marketing category ANDA
Marketing start 2023-04-24
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 1 .
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 A078404-001 BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 A078404-002 BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078404-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2012-07-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078404-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2012-07-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Budesonide Inhalation
Listing expiration 2027-12-31 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 68788-8429-3 Budesonide Inhalation 5 in 1 POUCH SUSPENSION 5 4 68788-8429-3 Budesonide Inhalation 6 in 1 CARTON SUSPENSION 6 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8429 BUDESONIDE INHALATION (BUDESONIDE) SUSPENSION [PREFERRED PHARMACEUTICALS INC.] 3 Current NDC, 2 package rows 20250210_1d139a25-9c17-4b3e-8ffd-b2d562cc00ee.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 · 2 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 68788-8429-3 68788842903 6 POUCH in 1 CARTON (68788-8429-3) / 5 VIAL in 1 POUCH / 2 mL in 1 VIAL 6 pouch 2023-04-24 No No Current