Budesonide
- Product NDC
- 0378-7155
- 11-digit product format
- 003787155
- Labeler code
- 0378
- Product ID
- 0378-7155_7c36dbe2-e957-4045-b7a5-7321a7af50b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- budesonide
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals 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 [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-7155-01 | EA - Each | 0378-7155 | 4f6e5f1c-0fab-44ed-bc20-0b33d4275987 | 1 | 2012-07-24 |
| 0378-7155-05 | EA - Each | 0378-7155 | 83afd047-ea72-4088-b4fb-d816ee8ec1f8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0378-7155-01 | 00378715501 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-7155-01) | 100 capsule | 2011-05-16 | 0000-00-00 | No | No | Current |