Home NDC 0245-0813-13 KYMBEE
Product NDC 0245-0813
Requested package NDC 0245-0813-13
11-digit product format 002450813
Labeler code 0245
Product ID 0245-0813_548be9b3-be2c-7d81-e063-6394a90a8793
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Deflazacort
Dosage form SUSPENSION
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA216992
Marketing category ANDA
Marketing start 2026-06-05
Substance DEFLAZACORT
Active strength 22.75 mg/mL
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 43 .
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 A216992-001 DEFLAZACORT DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2025-08-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216992-001 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 2026-09-14 22:38:34 2026-08 A216992-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2025-08-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216992-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2025-08-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216992-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2025-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216992-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2025-08-11 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216992-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2025-08-11 a50c72e98297…
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 KYMBEE
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1870964 Internal RxNorm lookup 2745410 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0245-0813-13 00245081313 1 BOTTLE in 1 CARTON (0245-0813-13) / 13 mL in 1 BOTTLE 1 bottle 2026-06-05 No No Current