Home NDC 63629-8294-1 Budesonide
Product NDC 63629-8294
Requested package NDC 63629-8294-1
11-digit product format 636298294
Labeler code 63629
Product ID 63629-8294_a249352d-1d2d-4646-8a2b-81a2e37b7e86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Budesonide
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA206200
Marketing category ANDA
Marketing start 2017-09-15
Substance BUDESONIDE
Active strength 3 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 63629-8294 63629-8294-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A206200-001 BUDESONIDE BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206200-001 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 · 41 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 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206200-001 BUDESONIDE 3MG CAPSULE / ORAL AB 2017-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206200-001 BUDESONIDE 3MG CAPSULE / ORAL AB 2017-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206200-001 BUDESONIDE 3MG CAPSULE / ORAL AB 2017-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206200-001 BUDESONIDE 3MG CAPSULE / ORAL AB 2017-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206200-001 BUDESONIDE 3MG CAPSULE / ORAL AB 2017-07-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206200-001 BUDESONIDE 3MG CAPSULE / ORAL AB 2017-07-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206200-001 BUDESONIDE 3MG CAPSULE / ORAL AB 2017-07-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206200-001 BUDESONIDE 3MG CAPSULE / ORAL AB 2017-07-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-8294-1 Budesonide 30 in 1 BOTTLE CAPSULE, DELAYED RELEASE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8294 BUDESONIDE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK] 4 Current NDC, Legacy NDC, 1 package rows 20241109_4943ef5b-f48b-49d6-b419-467f71ef64e0.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 Marketing start Marketing end Sample Exclude flag Status 63629-8294-1 63629829401 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-8294-1) 2020-02-06 0000-00-00 No No Current