Home NDC 72205-178 pomalidomide
Product NDC 72205-178
11-digit product format 722050178
Labeler code 72205
Product ID 72205-178_b8c3b7f3-7e72-47af-be23-133e7bb3db59
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pomalidomide
Dosage form CAPSULE
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA210245
Marketing category ANDA
Marketing start 2026-09-02
Substance POMALIDOMIDE
Active strength 3 mg/1
Pharmacologic classes Thalidomide Analog [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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210245-001 POMALIDOMIDE POMALIDOMIDE 2MG CAPSULE / ORAL AB 2026-09-02 A210245-002 POMALIDOMIDE POMALIDOMIDE 3MG CAPSULE / ORAL AB 2026-09-02 A210245-003 POMALIDOMIDE POMALIDOMIDE 4MG CAPSULE / ORAL AB 2026-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2026-09-14 22:38:34 2026-08 A210245-001 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2026-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210245-002 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2026-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210245-003 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2026-09-02 84e616aacf4f…
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 pomalidomide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POMALIDOMIDE 3 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72205-178-21 72205017821 21 CAPSULE in 1 BOTTLE, PLASTIC (72205-178-21) 21 capsule 2026-09-02 No No Current 72205-178-91 72205017891 100 CAPSULE in 1 BOTTLE, PLASTIC (72205-178-91) 100 capsule 2026-09-02 No No Current