Home NDC 13107-231-54 Beclomethasone Dipropionate
Product NDC 13107-231
Requested package NDC 13107-231-54
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 · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214418-001 BECLOMETHASONE DIPROPIONATE BECLOMETHASONE DIPROPIONATE 0.04MG/INH AEROSOL, METERED / INHALATION AB 2026-09-14 A214418-002 BECLOMETHASONE DIPROPIONATE BECLOMETHASONE DIPROPIONATE 0.08MG/INH AEROSOL, METERED / INHALATION AB 2026-09-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A214418-001 BECLOMETHASONE DIPROPIONATE 0.04MG/INH AEROSOL, METERED / INHALATION AB 2026-09-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214418-002 BECLOMETHASONE DIPROPIONATE 0.08MG/INH AEROSOL, METERED / INHALATION AB 2026-09-14 c2088c7a36db…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A214418-001 AB 1 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214418-002 AB 1 c2088c7a36db…
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