Home NDC 70095-043 Deflazacort
Product NDC 70095-043
11-digit product format 700950043
Labeler code 70095
Product ID 70095-043_4583474c-40e7-dd9d-e063-6294a90a902a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Deflazacort
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA217741
Marketing category ANDA
Marketing start 2025-03-19
Substance DEFLAZACORT
Active strength 36 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A217741-001 DEFLAZACORT DEFLAZACORT 6MG TABLET / ORAL AB 2025-03-18 A217741-002 DEFLAZACORT DEFLAZACORT 18MG TABLET / ORAL AB 2025-03-18 A217741-003 DEFLAZACORT DEFLAZACORT 30MG TABLET / ORAL AB 2025-03-18 A217741-004 DEFLAZACORT DEFLAZACORT 36MG TABLET / ORAL AB 2025-03-18
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 2026-02-19 14:30 UTC 2026-02 A217741-001 DEFLAZACORT 6MG TABLET / ORAL AB 2025-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217741-002 DEFLAZACORT 18MG TABLET / ORAL AB 2025-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217741-003 DEFLAZACORT 30MG TABLET / ORAL AB 2025-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217741-004 DEFLAZACORT 36MG TABLET / ORAL AB 2025-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217741-001 DEFLAZACORT 6MG TABLET / ORAL AB 2025-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217741-002 DEFLAZACORT 18MG TABLET / ORAL AB 2025-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217741-003 DEFLAZACORT 30MG TABLET / ORAL AB 2025-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217741-004 DEFLAZACORT 36MG TABLET / ORAL AB 2025-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217741-001 DEFLAZACORT 6MG TABLET / ORAL AB 2025-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217741-002 DEFLAZACORT 18MG TABLET / ORAL AB 2025-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217741-003 DEFLAZACORT 30MG TABLET / ORAL AB 2025-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217741-004 DEFLAZACORT 36MG TABLET / ORAL AB 2025-03-18 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217741-001 DEFLAZACORT 6MG TABLET / ORAL AB 2025-03-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217741-002 DEFLAZACORT 18MG TABLET / ORAL AB 2025-03-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217741-003 DEFLAZACORT 30MG TABLET / ORAL AB 2025-03-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217741-004 DEFLAZACORT 36MG TABLET / ORAL AB 2025-03-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Deflazacort
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFLAZACORT 36 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KR5YZ6AE4B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153098 Internal RxNorm lookup 153880 Internal RxNorm lookup 1870954 Internal RxNorm lookup 1870958 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70095-043-30 Deflazacort 1 in 1 CARTON TABLET 1 2 70095-043-30 Deflazacort 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70095-043 DEFLAZACORT TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED] 1 Current NDC, 2 package rows 20250321_fb5350d5-ead1-41f4-8b25-0da0bd7fcffe.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70095-043-30 70095004330 1 BOTTLE in 1 CARTON (70095-043-30) / 30 TABLET in 1 BOTTLE 1 bottle 2025-03-19 No No Current