Budesonide and Formoterol Fumarate Dihydrate
- Product NDC
- 70518-3107
- 11-digit product format
- 705183107
- Labeler code
- 70518
- Product ID
- 70518-3107_e3aee691-e4cc-a959-e053-2a95a90ae51b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide and Formoterol Fumarate Dihydrate
- Dosage form
- AEROSOL
- Route
- RESPIRATORY (INHALATION)
- Labeler
- REMEDYREPACK INC.
- Application
- NDA021929
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2021-05-27
- Marketing end
- 0000-00-00
- Substance
- BUDESONIDE; FORMOTEROL FUMARATE
- Active strength
- 160 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3107-0 | 70518310700 | 1 POUCH in 1 CARTON (70518-3107-0) > 1 CANISTER in 1 POUCH > 120 AEROSOL in 1 CANISTER | 1 pouch | 2021-05-27 | 0000-00-00 | No | No | Current |