Home NDC 0093-6815 Budesonide
Product NDC 0093-6815
11-digit product format 000936815
Labeler code 0093
Product ID 0093-6815_551a929a-3517-4e58-9df6-f9bfb0f2f3be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Budesonide
Dosage form SUSPENSION
Route RESPIRATORY (INHALATION)
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA077519
Marketing category ANDA
Marketing start 2019-01-11
Substance BUDESONIDE
Active strength .25 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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base Budesonide
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUDESONIDE ACTIVE INGREDIENT Q3OKS62Q6X BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] 8 BUDESONIDE ACTIVE MOIETY Q3OKS62Q6X BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] 8 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] 8 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] 8 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] 8 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] 8 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] 8 WATER INACTIVE INGREDIENT 059QF0KO0R BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC] 8 BUDESONIDE ACTIVE INGREDIENT Q3OKS62Q6X BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 BUDESONIDE ACTIVE MOIETY Q3OKS62Q6X BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R BUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-6815 BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA, INC.] 13 Current NDC, Legacy NDC, 5 package rows 20210626_2414058b-5d39-42f2-915f-03a5e1101ab5.zip 0093-6815 BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20210626_4f126a29-38f7-4c4c-8978-37e72b289902.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 Marketing start Marketing end Sample Exclude flag Status 0093-6815-19 00093681519 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 0093-6815-45 00093681545 5 in 1 POUCH Historical 0093-6815-55 00093681555 30 POUCH in 1 CARTON (0093-6815-55) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE 30 pouch 2019-01-11 0000-00-00 No No Current 0093-6815-73 00093681573 6 POUCH in 1 CARTON (0093-6815-73) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-6815-45) / 2 mL in 1 VIAL, SINGLE-DOSE (0093-6815-19) 6 pouch 2008-11-19 0000-00-00 No No Current 0093-6815-76 00093681576 2 POUCH in 1 CARTON (0093-6815-76) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE 2 pouch 2008-11-19 0000-00-00 No No Current