Budesonide and Formoterol Fumarate Dihydrate
- Product NDC
- 53002-2666
- 11-digit product format
- 530022666
- Labeler code
- 53002
- Product ID
- 53002-2666_8414c769-98d1-4d0a-9140-b787ccae9b73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide and Formoterol Fumarate Dihydrate
- Dosage form
- AEROSOL
- Route
- RESPIRATORY (INHALATION)
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- NDA021929
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-01-03
- Marketing end
- 0000-00-00
- Substance
- BUDESONIDE; FORMOTEROL FUMARATE
- Active strength
- 80 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2666-1 | Budesonide and Formoterol Fumarate Dihydrate | 1 in 1 CARTON | AEROSOL | 1 | | 1 |
| 53002-2666-1 | Budesonide and Formoterol Fumarate Dihydrate | 1 in 1 POUCH | AEROSOL | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2666 | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE AEROSOL [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 2 package rows | 20220331_bbd0a8f7-d855-41cc-b6b0-70fe2f20d079.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-2666-1 | 53002266601 | 1 POUCH in 1 CARTON (53002-2666-1) > 1 AEROSOL in 1 POUCH | 1 pouch | 2021-01-01 | 0000-00-00 | No | No | Current |