Home NDC 70121-2250 ROMIDEPSIN
Product NDC 70121-2250
11-digit product format 701212250
Labeler code 70121
Product ID 70121-2250_a007605f-1e3d-4174-b62c-999ebbe27ed5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ROMIDEPSIN
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA219099
Marketing category ANDA
Marketing start 2026-06-02
Substance ROMIDEPSIN
Active strength 5 mg/mL
Pharmacologic classes Bile Salt Export Pump Inhibitors [MoA], Histone Deacetylase Inhibitor [EPC], Histone Deacetylase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
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 A219099-001 ROMIDEPSIN ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) SOLUTION / INTRAVENOUS RS 2026-06-02
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A219099-001 CGT 2026-12-07
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 A219099-001 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) SOLUTION / INTRAVENOUS RS 2026-06-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219099-001 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) SOLUTION / INTRAVENOUS RS 2026-06-02 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219099-001 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) SOLUTION / INTRAVENOUS RS 2026-06-02 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 A219099-001 CGT 2026-12-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219099-001 CGT 2026-12-07 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219099-001 CGT 2026-12-07 a50c72e98297…
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 Active Ingredients# Ingredient, Strength table Ingredient Strength ROMIDEPSIN 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CX3T89XQBK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2289413 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 70121-2250-1 70121225001 1 VIAL in 1 CARTON (70121-2250-1) / 5.5 mL in 1 VIAL 1 vial 2026-06-02 No No Current