Budesonide and Formoterol Fumarate Dihydrate
- Product NDC
- 53002-2667
- 11-digit product format
- 530022667
- Labeler code
- 53002
- Product ID
- 53002-2667_ed2f9421-5a02-4d2b-b1c0-6c1f4f03ed32
- 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
- 160 ug/1; ug/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 53002-2667-1 | Budesonide and Formoterol Fumarate Dihydrate | 1 in 1 CARTON | AEROSOL | 1 | | 1 |
| 53002-2667-1 | 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 |
|---|
| 53002-2667 | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE AEROSOL [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 2 package rows | 20201222_ca94e217-1828-4a7f-b7c3-3352f00a97d3.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 |
|---|
| 53002-2667-1 | 53002266701 | 1 POUCH in 1 CARTON (53002-2667-1) > 1 AEROSOL in 1 POUCH | 1 pouch | 2020-01-03 | 0000-00-00 | No | No | Current |