Beclomethasone Dipropionate
- Product NDC
- 13107-231
- 11-digit product format
- 131070231
- Labeler code
- 13107
- Product ID
- 13107-231_a27795ec-4309-4a40-8dc2-12d0ec5bf12b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Beclomethasone Dipropionate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Aurolife Pharma LLC
- Application
- ANDA214418
- Marketing category
- ANDA
- Marketing start
- 2026-09-14
- Substance
- BECLOMETHASONE DIPROPIONATE
- Active strength
- 80 ug/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Beclomethasone Dipropionate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BECLOMETHASONE DIPROPIONATE | 80 ug/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 13107-231-54 | 13107023154 | 1 CANISTER in 1 CARTON (13107-231-54) / 120 AEROSOL, METERED in 1 CANISTER | 1 canister | 2026-09-14 | No | No | Current |