Home NDC 0574-9855 budesonide
Product NDC 0574-9855
11-digit product format 005749855
Labeler code 0574
Product ID 0574-9855_d502ff68-2ba4-461c-a739-9012f4f09dec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name budesonide
Dosage form CAPSULE
Route ORAL
Labeler Padagis US LLC
Application NDA021324
Marketing category NDA
Marketing start 2018-06-29
Substance BUDESONIDE
Active strength 3 mg/1
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 43 .
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 N021324-001 ENTOCORT EC BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021324-001 AB
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 · 43 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 2026-09-14 22:38:34 2026-08 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021324-001 ENTOCORT EC 3MG CAPSULE / ORAL AB RLD, RS 2001-10-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021324-001 ENTOCORT EC 3MG CAPSULE / ORAL AB RLD, RS 2001-10-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021324-001 ENTOCORT EC 3MG CAPSULE / ORAL AB RLD, RS 2001-10-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021324-001 ENTOCORT EC 3MG CAPSULE / ORAL AB RLD, RS 2001-10-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021324-001 ENTOCORT EC 3MG CAPSULE / ORAL AB RLD, RS 2001-10-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021324-001 ENTOCORT EC 3MG CAPSULE / ORAL AB RLD, RS 2001-10-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021324-001 ENTOCORT EC 3MG CAPSULE / ORAL AB RLD, RS 2001-10-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021324-001 ENTOCORT EC 3MG CAPSULE / ORAL AB RLD, RS 2001-10-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021324-001 ENTOCORT EC 3MG CAPSULE, DELAYED RELEASE / ORAL AB RLD, RS 2001-10-02 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 N021324-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021324-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021324-001 AB 1 a50c72e98297…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base budesonide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUDESONIDE 3 mg/1
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 1244214 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 0574-9855-10 budesonide 100 in 1 BOTTLE CAPSULE 100 10 0574-9855-10 budesonide 1 in 1 CARTON CAPSULE 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-9855 BUDESONIDE CAPSULE [PADAGIS US LLC] 9 Current NDC, Legacy NDC, 2 package rows 20241127_3a18d5a7-04c5-4137-8155-70a8adc0a48b.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 0574-9855-10 00574985510 1 BOTTLE in 1 CARTON (0574-9855-10) / 100 CAPSULE in 1 BOTTLE 1 bottle 2018-06-29 0000-00-00 No No Current