Home NDC 0054-0827 Deflazacort
Product NDC 0054-0827
11-digit product format 000540827
Labeler code 0054
Product ID 0054-0827_b019324e-dbd3-4404-a0b5-021d67c0270b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Deflazacort
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA220524
Marketing category ANDA
Marketing start 2026-10-07
Substance DEFLAZACORT
Active strength 36 mg/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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220524-001 DEFLAZACORT DEFLAZACORT 6MG TABLET / ORAL AB 2026-09-18 A220524-002 DEFLAZACORT DEFLAZACORT 18MG TABLET / ORAL AB 2026-09-18 A220524-003 DEFLAZACORT DEFLAZACORT 30MG TABLET / ORAL AB 2026-09-18 A220524-004 DEFLAZACORT DEFLAZACORT 36MG TABLET / ORAL AB 2026-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 A220524-001 DEFLAZACORT 6MG TABLET / ORAL AB 2026-09-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220524-002 DEFLAZACORT 18MG TABLET / ORAL AB 2026-09-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220524-003 DEFLAZACORT 30MG TABLET / ORAL AB 2026-09-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220524-004 DEFLAZACORT 36MG TABLET / ORAL AB 2026-09-18 c2088c7a36db…
Observed Orange Book normalized TE history# 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 Deflazacort
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFLAZACORT 36 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0054-0827-13 00054082713 30 TABLET in 1 BOTTLE (0054-0827-13) 30 tablet 2026-10-07 No No Current