Budesonide

Product NDC
60429-264
11-digit product format
604290264
Labeler code
60429
Product ID
60429-264_dc7893b3-ab13-a191-e053-2a95a90ac42d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
budesonide
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA090410
Marketing category
ANDA
Marketing start
2011-05-16
Marketing end
2022-08-31
Substance
BUDESONIDE
Active strength
3 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60429-264DDiscontinued by firm2026-08-03
excluded packagepackage60429-26460429-264-01DDiscontinued by firm2026-08-03

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60429-264-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60429-264-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60429-264-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60429-264-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60429-264-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60429-264-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60429-264-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60429-264-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60429-264-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60429-264-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60429-264-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60429-264-01557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090410-001BUDESONIDEBUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090410-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090410-001BUDESONIDE3MGCAPSULE / ORALAB2011-05-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090410-001BUDESONIDE3MGCAPSULE / ORALAB2011-05-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A090410-001BUDESONIDE3MGCAPSULE / ORALAB2011-05-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090410-001BUDESONIDE3MGCAPSULE / ORALAB2011-05-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090410-001BUDESONIDE3MGCAPSULE / ORALAB2011-05-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090410-001BUDESONIDE3MGCAPSULE / ORALAB2011-05-163f01610625f2…
2019-09-15 20:21 UTC2019-09A090410-001BUDESONIDE3MGCAPSULE / ORALAB2011-05-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A090410-001BUDESONIDE3MGCAPSULE / ORALAB2011-05-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090410-001BUDESONIDE3MGCAPSULE, DELAYED RELEASE / ORALAB2011-05-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090410-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090410-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090410-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090410-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090410-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090410-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090410-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090410-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090410-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090410-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090410-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090410-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090410-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090410-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090410-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090410-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090410-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090410-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090410-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090410-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090410-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090410-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090410-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090410-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090410-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090410-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090410-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090410-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090410-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090410-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090410-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090410-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090410-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090410-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090410-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090410-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090410-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090410-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090410-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090410-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-264-01EA - Each60429-264a99c24ad-4e69-42b3-bb96-6272b2270e2312015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-264-0160429026401100 CAPSULE in 1 BOTTLE, PLASTIC (60429-264-01) 100 capsule2015-07-100000-00-00NoNoCurrent