Home NDC 31722-301 Eltrombopag
Product NDC 31722-301
11-digit product format 317220301
Labeler code 31722
Product ID 31722-301_315730ec-c40c-af1a-e063-6294a90a010f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eltrombopag olamine
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA216620
Marketing category ANDA
Marketing start 2025-05-13
Substance ELTROMBOPAG OLAMINE
Active strength 25 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216620-001 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB 2024-04-18 A216620-002 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB 2024-04-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-08-01 22:54:32 2026-06 A216620-001 ELTROMBOPAG OLAMINE EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB 2024-04-18 a50c72e98297…2026-08-01 22:54:32 2026-06 A216620-002 ELTROMBOPAG OLAMINE EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB 2024-04-18 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A216620-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A216620-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Eltrombopag
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELTROMBOPAG OLAMINE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4U07F515LG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1859498 Internal RxNorm lookup 2058980 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 31722-301-25 Eltrombopag 1 in 1 PACKET POWDER, FOR SUSPENSION 1 1 31722-301-31 Eltrombopag 30 in 1 CARTON POWDER, FOR SUSPENSION 30 1 31722-301-32 Eltrombopag 1 in 1 KIT POWDER, FOR SUSPENSION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-301 ELTROMBOPAG (ELTROMBOPAG OLAMINE) POWDER, FOR SUSPENSION [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, 3 package rows 20250514_8f6499f0-4774-4f1e-8ab5-145c1fe64401.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 31722-301-25 31722030125 1 in 1 PACKET Historical 31722-301-31 31722030131 30 in 1 CARTON Historical 31722-301-32 31722030132 1 CARTON in 1 KIT (31722-301-32) / 30 PACKET in 1 CARTON (31722-301-31) / 1 POWDER, FOR SUSPENSION in 1 PACKET (31722-301-25) 1 carton 2025-05-13 No No Current