Home NDC 27808-249 Deflazacort Oral Suspension
Product NDC 27808-249
11-digit product format 278080249
Labeler code 27808
Product ID 27808-249_efc7fb53-ed0f-4ec1-a6ce-dee55f0064d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Deflazacort Oral
Dosage form SUSPENSION
Route ORAL
Labeler Cranbury Pharmaceuticals, LLC
Application ANDA217813
Marketing category ANDA
Marketing start 2024-05-01
Substance DEFLAZACORT
Active strength 22.75 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217813-001 DEFLAZACORT DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217813-001 AB
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 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217813-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2024-04-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Deflazacort Oral Suspension
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFLAZACORT 22.75 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1870964 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 27808-249-01 Deflazacort Oral Suspension 13 mL in 1 BOTTLE SUSPENSION 13 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27808-249 DEFLAZACORT ORAL SUSPENSION (DEFLAZACORT ORAL) SUSPENSION [TRIS PHARMA INC] 7 Current NDC, 1 package rows 20240726_881785a5-41b4-4679-a29b-5d77ca51ca60.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 27808-249-01 27808024901 13 mL in 1 BOTTLE (27808-249-01) 13 ml 2024-05-01 No No Current