Home NDC 0093-6817 Budesonide
Product NDC 0093-6817
11-digit product format 000936817
Labeler code 0093
Product ID 0093-6817_e505244f-d53f-4dc0-acd7-45dc98034b97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Budesonide
Dosage form SUSPENSION
Route RESPIRATORY (INHALATION)
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA204548
Marketing category ANDA
Marketing start 2016-03-11
Substance BUDESONIDE
Active strength 1 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 A204548-001 BUDESONIDE BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204548-001 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 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204548-001 BUDESONIDE 1MG/2ML SUSPENSION / INHALATION AN 2016-03-08 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
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 252559 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 0093-6817-19 Budesonide 2 mL in 1 AMPULE SUSPENSION 2 5 0093-6817-45 Budesonide 5 in 1 POUCH SUSPENSION 5 5 0093-6817-73 Budesonide 6 in 1 CARTON SUSPENSION 6 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-6817 BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA, INC.] 5 Current NDC, Legacy NDC, 3 package rows 20200416_d90ffda1-12c7-4726-90e9-64bb103e84b5.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 · 1 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 0093-6817-19 00093681719 2 mL in 1 AMPULE 2 ml Historical 0093-6817-45 00093681745 5 in 1 POUCH Historical 0093-6817-73 00093681773 6 POUCH in 1 CARTON (0093-6817-73) / 5 AMPULE in 1 POUCH (0093-6817-45) / 2 mL in 1 AMPULE (0093-6817-19) 6 pouch 2016-03-11 0000-00-00 No No Current