BUDESONIDE
- Product NDC
- 45802-627
- 11-digit product format
- 458020627
- Labeler code
- 45802
- Product ID
- 45802-627_ad4a68e7-9200-4f05-8058-714d5d8900f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- budesonide
- Dosage form
- AEROSOL, FOAM
- Route
- RECTAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA215328
- Marketing category
- ANDA
- Marketing start
- 2023-04-17
- Substance
- BUDESONIDE
- Active strength
- 2 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUDESONIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUDESONIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3OKS62Q6X |
| Rxcui | 1596779 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-627-01 | BUDESONIDE | 1 in 1 CANISTER | AEROSOL, FOAM | 1 | | 1 |
| 45802-627-86 | BUDESONIDE | 2 in 1 CARTON | AEROSOL, FOAM | 2 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-627 | BUDESONIDE AEROSOL, FOAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 1 | Current NDC, 2 package rows | 20230418_ad4a68e7-9200-4f05-8058-714d5d8900f8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 45802-627-01 | 45802062701 | 1 in 1 CANISTER | | | | | Historical |
| 45802-627-86 | 45802062786 | 2 CANISTER in 1 CARTON (45802-627-86) / 1 AEROSOL, FOAM in 1 CANISTER (45802-627-01) | 2 canister | 2023-04-17 | No | No | Current |