Home NDC 53746-778 Budesonide
Product NDC 53746-778
11-digit product format 537460778
Labeler code 53746
Product ID 53746-778_6c4112fe-354a-472f-97ba-fa86d405b7f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Budesonide
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA206200
Marketing category ANDA
Marketing start 2025-05-22
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 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 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 · 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 A206200-001 BUDESONIDE 3MG CAPSULE, DELAYED RELEASE / ORAL AB 2017-07-31 caaa826d4ba7…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…
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 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 53746-778-10 Budesonide 100 in 1 BOTTLE CAPSULE, DELAYED RELEASE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-778 BUDESONIDE CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 1 Current NDC, 1 package rows 20250523_10336e42-0e9d-45c4-80bc-5149d5ec9e1c.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 Sample Exclude flag Status 53746-778-10 53746077810 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53746-778-10) 2025-05-22 No No Current