Dulera
- Product NDC
- 0085-4610
- 11-digit product format
- 000854610
- Labeler code
- 0085
- Product ID
- 0085-4610_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
- 2010-06-22
- Marketing end
- 0000-00-00
- Substance
- MOMETASONE FUROATE; FORMOTEROL FUMARATE
- Active strength
- 200 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 |
|---|
| 0085-4610-01 | 00085461001 | 1 CANISTER in 1 CARTON (0085-4610-01) > 120 AEROSOL in 1 CANISTER | 1 canister | 2010-06-22 | 0000-00-00 | No | No | Current |
| 0085-4610-02 | 00085461002 | 1 CANISTER in 1 CARTON (0085-4610-02) > 120 AEROSOL in 1 CANISTER | 1 canister | 2010-06-22 | 0000-00-00 | No | No | Current |
| 0085-4610-05 | 00085461005 | 1 CANISTER in 1 CARTON (0085-4610-05) > 60 AEROSOL in 1 CANISTER | 1 canister | 2010-06-22 | 0000-00-00 | No | No | Current |
| 0085-4610-06 | 00085461006 | 1 CANISTER in 1 CARTON (0085-4610-06) > 60 AEROSOL in 1 CANISTER | 1 canister | 2010-06-22 | 0000-00-00 | No | No | Current |