Romidepsin

Product NDC
70710-2183
11-digit product format
707102183
Labeler code
70710
Product ID
70710-2183_366befa0-ebcc-4484-b8a1-6f7d25fe6120
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Romidepsin
Dosage form
KIT
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA220783
Marketing category
ANDA
Marketing start
2026-11-01
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

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
Romidepsin
Listing expiration
2027-12-31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-2183-3707102183031 KIT in 1 CARTON (70710-2183-3) * 2 mL in 1 VIAL, GLASS (70710-2181-1) * 2.2 mL in 1 VIAL, GLASS (70710-2182-1) 1 kit2026-11-01YesNoHistorical