Home NDC 69097-037 Pomalidomide
Product NDC 69097-037
11-digit product format 690970037
Labeler code 69097
Product ID 69097-037_d7629b96-2ace-4a2e-a70c-e73d41a990f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pomalidomide
Dosage form CAPSULE
Route ORAL
Labeler Cipla USA Inc.
Application ANDA219718
Marketing category ANDA
Marketing start 2026-08-30
Substance POMALIDOMIDE
Active strength 2 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219718-001 POMALIDOMIDE POMALIDOMIDE 1MG CAPSULE / ORAL AB 2026-08-31 A219718-002 POMALIDOMIDE POMALIDOMIDE 2MG CAPSULE / ORAL AB 2026-08-31 A219718-003 POMALIDOMIDE POMALIDOMIDE 3MG CAPSULE / ORAL AB 2026-08-31 A219718-004 POMALIDOMIDE POMALIDOMIDE 4MG CAPSULE / ORAL AB 2026-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 A219718-001 POMALIDOMIDE 1MG CAPSULE / ORAL AB 2026-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219718-002 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2026-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219718-003 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2026-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219718-004 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2026-08-31 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 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D2UX06XLB5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1369718 Internal RxNorm lookup 1369726 Internal RxNorm lookup 1369730 Internal RxNorm lookup 1369734 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 69097-037-07 69097003707 100 CAPSULE in 1 BOTTLE (69097-037-07) 100 capsule 2026-08-30 No No Current 69097-037-81 69097003781 21 CAPSULE in 1 BOTTLE (69097-037-81) 21 capsule 2026-08-30 No No Current