Home NDC 69097-321 Budesonide
Product NDC 69097-321
11-digit product format 690970321
Labeler code 69097
Product ID 69097-321_58158207-1901-422d-8d42-323dab348a01
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Budesonide
Dosage form INHALANT
Route ORAL
Labeler Cipla USA Inc.
Application ANDA205710
Marketing category ANDA
Marketing start 2017-11-16
Substance BUDESONIDE
Active strength 1 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205710-001 BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 A205710-002 BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 A205710-003 BUDESONIDE BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16
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 4 · 123 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 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205710-002 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2017-11-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205710-003 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2017-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205710-001 BUDESONIDE 0.25MG/2ML SUSPENSION / INHALATION AN 2017-11-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Budesonide
Brand name suffix Inhalation Suspension
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUDESONIDE 1 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 252559 Internal RxNorm lookup 349094 Internal RxNorm lookup 351109 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 69097-321-32 BudesonideInhalation Suspension 2 mL in 1 AMPULE INHALANT 2 12 69097-321-32 BudesonideInhalation Suspension 1 in 1 POUCH INHALANT 1 12 69097-321-53 BudesonideInhalation Suspension 30 in 1 CARTON INHALANT 30 12 69097-321-86 BudesonideInhalation Suspension 2 mL in 1 AMPULE INHALANT 2 12 69097-321-86 BudesonideInhalation Suspension 5 in 1 POUCH INHALANT 5 12 69097-321-87 BudesonideInhalation Suspension 6 in 1 CARTON INHALANT 6 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-321 BUDESONIDE INHALATION SUSPENSION (BUDESONIDE) INHALANT [CIPLA USA INC.] 11 Current NDC, Legacy NDC, 6 package rows 20240822_c52c5382-1400-44b9-95be-a30e1cf706da.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69097-321-32 69097032132 2 mL in 1 AMPULE 2 ml Historical 69097-321-53 69097032153 30 POUCH in 1 CARTON (69097-321-53) / 1 AMPULE in 1 POUCH (69097-321-32) / 2 mL in 1 AMPULE 30 pouch 2020-04-10 0000-00-00 No No Current 69097-321-86 69097032186 2 mL in 1 AMPULE 2 ml Historical 69097-321-87 69097032187 6 POUCH in 1 CARTON (69097-321-87) / 5 AMPULE in 1 POUCH (69097-321-86) / 2 mL in 1 AMPULE 6 pouch 2017-11-16 0000-00-00 No No Current