Budesonide
- Product NDC
- 68151-4374
- 11-digit product format
- 681514374
- Labeler code
- 68151
- Product ID
- 68151-4374_4e0daaa9-b926-4033-93c4-47fefd919ed3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- budesonide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- ANDA090410
- Marketing category
- ANDA
- Marketing start
- 2013-08-23
- Marketing end
- 0000-00-00
- Substance
- BUDESONIDE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7816cdf6-b925-4282-bedd-11ae25d518a1 | Product name | 1 | 20250116 |
| d17a61d0-e77b-4bcb-ad22-343ff1a3ef4d | Product name | 2 | 20240424 |
| 9ab9f611-cedd-47ea-a83c-0489c8c04fc6 | Product name | 1 | 20231006 |
| c76bcd0f-25eb-471e-b970-1956c95c26c5 | Product name | 1 | 20230425 |
| a03aea00-1d8b-bfad-a82e-f52f68676f63 | Product name | 2 | 20221216 |
| 54a29484-7dde-4771-9547-005149321621 | Product name | 1 | 20220720 |
| 793b53dd-c0ea-da17-9ac0-fb5c4a6e0743 | Product name | 5 | 20211018 |
| 218c043e-94e5-4e66-a363-d0d446485bc6 | Product name | 2 | 20210512 |
| 7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a | Product name | 1 | 20210204 |
| 5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7 | Product name | 9 | 20210127 |
| da63bc8c-2e89-4044-89d6-1facbff5474e | Product name | 1 | 20200121 |
| 899766bc-33ce-8154-910d-12cb0889fb56 | Product name | 2 | 20150106 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-4374-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cb47-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1997 budesonide capsules (enteric coated) budesonide capsules (enteric coated) BUDESONIDE capsules (enteric coated), for oral use |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-4374-0 | Budesonide | 1 in 1 PACKAGE | CAPSULE | 1 | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-4374 | BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | Legacy NDC, 1 package rows | 20140820_7633c9b3-dfb5-446f-a260-e44b6e48afa2.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1244214 | budesonide 3 MG Delayed Release Oral Capsule | PSN | 7633c9b3-dfb5-446f-a260-e44b6e48afa2 | 2 |
| 1244214 | budesonide 3 MG Delayed Release Oral Capsule | SCD | 7633c9b3-dfb5-446f-a260-e44b6e48afa2 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-4374-0 | 68151437400 | 1 in 1 PACKAGE | Historical |