Dulera
- Product NDC
- 0085-2223
- 11-digit product format
- 000852223
- Labeler code
- 0085
- Product ID
- 0085-2223_1ef5a40c-4197-4f13-aec6-51c20412bbad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mometasone furoate and formoterol fumarate dihydrate
- Dosage form
- AEROSOL
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Merck Sharp & Dohme Corp.
- Application
- NDA022518
- Marketing category
- NDA
- Marketing start
- 2019-08-12
- Marketing end
- 0000-00-00
- Substance
- MOMETASONE FUROATE; FORMOTEROL FUMARATE
- Active strength
- 50 ug/1; ug/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],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
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0085-2223-01 | 00085222301 | 1 CANISTER in 1 CARTON (0085-2223-01) > 120 AEROSOL in 1 CANISTER | 1 canister | 2019-08-12 | 0000-00-00 | No | No | Current |
| 0085-2223-02 | 00085222302 | 1 CANISTER in 1 CARTON (0085-2223-02) > 120 AEROSOL in 1 CANISTER | 1 canister | 2019-08-12 | 0000-00-00 | Yes | No | Current |