Home NDC 0480-3273 ALVAIZ
Product NDC 0480-3273
11-digit product format 004803273
Labeler code 0480
Product ID 0480-3273_a573cf28-59db-4cb3-84db-af7b77200b66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eltrombopag
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application NDA216774
Marketing category NDA
Marketing start 2024-02-13
Substance ELTROMBOPAG CHOLINE
Active strength 9 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 2027-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216774-001 ALVAIZ ELTROMBOPAG CHOLINE EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 N216774-002 ALVAIZ ELTROMBOPAG CHOLINE EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 N216774-003 ALVAIZ ELTROMBOPAG CHOLINE EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 N216774-004 ALVAIZ ELTROMBOPAG CHOLINE EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216774-001 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 N216774-001 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 N216774-001 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 N216774-002 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 N216774-002 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 N216774-002 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 N216774-003 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 N216774-003 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 N216774-003 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 N216774-004 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 N216774-004 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 N216774-004 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22
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 N216774-001 ALVAIZ EQ 9MG BASE TABLET / ORAL RLD 2023-11-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-002 ALVAIZ EQ 18MG BASE TABLET / ORAL RLD 2023-11-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-003 ALVAIZ EQ 36MG BASE TABLET / ORAL RLD 2023-11-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-004 ALVAIZ EQ 54MG BASE TABLET / ORAL RLD, RS 2023-11-29 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N216774-001 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-001 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-001 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-002 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-002 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-002 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-003 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-003 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-003 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-004 11072586 2038-11-05 U-3937 Drug substance, Drug product 2024-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-004 11072586 2038-11-05 U-3938 Drug substance, Drug product 2024-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216774-004 11072586 2038-11-05 U-3936 Drug substance, Drug product 2024-05-22 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ALVAIZ ELTROMBOPAG Teva Pharmaceuticals, Inc. ed51e463-7a03-4858-bbd2-882ce4753d5a 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 216774 application number: NDA216774 ndc (product): 0480-3273
Additional Listing Data#
Finished product Yes
Brand name base ALVAIZ
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELTROMBOPAG CHOLINE 9 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F9G8XE24IB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2675187 Internal RxNorm lookup 2675193 Internal RxNorm lookup 2675195 Internal RxNorm lookup 2675197 Internal RxNorm lookup 2675199 Internal RxNorm lookup 2675201 Internal RxNorm lookup 2675203 Internal RxNorm lookup 2675205 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 0480-3273-56 ALVAIZ 30 in 1 BOTTLE TABLET, FILM COATED 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-3273 ALVAIZ (ELTROMBOPAG) TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] 4 Current NDC, 1 package rows 20250515_ed51e463-7a03-4858-bbd2-882ce4753d5a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0480-3273-56 00480327356 30 TABLET, FILM COATED in 1 BOTTLE (0480-3273-56) 2024-02-13 No No Current