Home NDC 60687-524 Budesonide Inhalation
Product NDC 60687-524
11-digit product format 606870524
Labeler code 60687
Product ID 60687-524_3765f418-7255-94d8-e063-6394a90ab595
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Budesonide Inhalation
Dosage form SUSPENSION
Route RESPIRATORY (INHALATION)
Labeler American Health Packaging
Application ANDA210897
Marketing category ANDA
Marketing start 2020-01-06
Substance BUDESONIDE
Active strength .5 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210897-001 BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210897-001 AN
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 2 · 42 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 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210897-001 BUDESONIDE 0.5MG/2ML SUSPENSION / INHALATION AN 2018-11-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Budesonide Inhalation
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUDESONIDE .5 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 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 60687-524-79 Budesonide Inhalation 1 in 1 POUCH SUSPENSION 1 5 60687-524-79 Budesonide Inhalation 2 mL in 1 AMPULE SUSPENSION 2 5 60687-524-83 Budesonide Inhalation 30 in 1 CARTON SUSPENSION 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-524 BUDESONIDE INHALATION SUSPENSION [AMERICAN HEALTH PACKAGING] 4 Current NDC, Legacy NDC, 3 package rows 20240731_45e5f304-1177-42a2-91c9-3ed1a9c9f8e6.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join budesonide inhalation BUDESONIDE INHALATION Preferred Pharmaceuticals, Inc. dd74e446-7c1b-4f02-9c73-ba716572ee77 2026-03-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210897 application number: ANDA210897 Budesonide Inhalation BUDESONIDE INHALATION American Health Packaging 45e5f304-1177-42a2-91c9-3ed1a9c9f8e6 2025-06-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210897 application number: ANDA210897 ndc (product): 60687-524 budesonide inhalation BUDESONIDE INHALATION A-S Medication Solutions 87048fa9-3391-4f30-801d-b96ca0132f56 2025-04-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210897 application number: ANDA210897 budesonide inhalation BUDESONIDE INHALATION Lupin Pharmaceuticals, Inc. 944cbb7c-b41d-4a6d-8a93-2e646365c982 2025-01-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210897 application number: ANDA210897
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 60687-524-79 60687052479 1 in 1 POUCH Historical 60687-524-83 60687052483 30 POUCH in 1 CARTON (60687-524-83) / 1 AMPULE in 1 POUCH (60687-524-79) / 2 mL in 1 AMPULE 30 pouch 2020-01-06 0000-00-00 No No Current