FDA.reportPublic FDA data

ALVAIZ

Product NDC
0480-3275
11-digit product format
004803275
Labeler code
0480
Product ID
0480-3275_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
36 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

Additional Listing Data#

Finished product
Yes
Brand name base
ALVAIZ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELTROMBOPAG CHOLINE36 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF9G8XE24IB
Rxcui2675187, 2675193, 2675195, 2675197, 2675199, 2675201, 2675203, 2675205

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
349df11e-99eb-4fff-8cd5-538adda21b14Product name320251110
4db6dd95-5e83-4752-b5e1-62f824423c50Product name120241217
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
fa996cde-a51d-4f68-1429-4f06c00a39f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-3275-56ALVAIZ30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3275-56EA - Each0480-32755d26bfc6-1a07-40e2-a5f6-cad04899944a12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-3275ALVAIZ (ELTROMBOPAG) TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]4Current NDC, 1 package rows20250515_ed51e463-7a03-4858-bbd2-882ce4753d5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675193Alvaiz 18 MG Oral TabletPSNed51e463-7a03-4858-bbd2-882ce4753d5a7
2675197Alvaiz 36 MG Oral TabletPSNed51e463-7a03-4858-bbd2-882ce4753d5a7
2675201Alvaiz 54 MG Oral TabletPSNed51e463-7a03-4858-bbd2-882ce4753d5a7
2675205Alvaiz 9 MG Oral TabletPSNed51e463-7a03-4858-bbd2-882ce4753d5a7
2675187eltrombopag 18 MG Oral TabletPSNed51e463-7a03-4858-bbd2-882ce4753d5a7
2675195eltrombopag 36 MG Oral TabletPSNed51e463-7a03-4858-bbd2-882ce4753d5a7
2675199eltrombopag 54 MG Oral TabletPSNed51e463-7a03-4858-bbd2-882ce4753d5a7
2675203eltrombopag 9 MG Oral TabletPSNed51e463-7a03-4858-bbd2-882ce4753d5a7
2675193eltrombopag 18 MG Oral Tablet [Alvaiz]SBDed51e463-7a03-4858-bbd2-882ce4753d5a7
2675197eltrombopag 36 MG Oral Tablet [Alvaiz]SBDed51e463-7a03-4858-bbd2-882ce4753d5a7
2675201eltrombopag 54 MG Oral Tablet [Alvaiz]SBDed51e463-7a03-4858-bbd2-882ce4753d5a7
2675205eltrombopag 9 MG Oral Tablet [Alvaiz]SBDed51e463-7a03-4858-bbd2-882ce4753d5a7
2675187eltrombopag 18 MG Oral TabletSCDed51e463-7a03-4858-bbd2-882ce4753d5a7
2675195eltrombopag 36 MG Oral TabletSCDed51e463-7a03-4858-bbd2-882ce4753d5a7
2675199eltrombopag 54 MG Oral TabletSCDed51e463-7a03-4858-bbd2-882ce4753d5a7
2675203eltrombopag 9 MG Oral TabletSCDed51e463-7a03-4858-bbd2-882ce4753d5a7
2675193Alvaiz 18 MG (as eltrombopag choline 22.2 MG) Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7
2675193Alvaiz 18 MG Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7
2675197Alvaiz 36 MG (as eltrombopag choline 44.4 MG) Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7
2675197Alvaiz 36 MG Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7
2675201Alvaiz 54 MG (eltrombopag choline 66.6 MG) Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7
2675201Alvaiz 54 MG Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7
2675205Alvaiz 9 MG (as eltrombopag choline 11.1 MG) Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7
2675205Alvaiz 9 MG Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7
2675187eltrombopag 18 MG (as eltrombopag choline 22.2 MG) Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7
2675195eltrombopag 36 MG (as eltrombopag choline 44.4 MG) Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7
2675199eltrombopag 54 MG (as eltrombopag choline 66.6 MG) Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7
2675203eltrombopag 9 MG (as eltrombopag choline 11.1 MG) Oral TabletSYed51e463-7a03-4858-bbd2-882ce4753d5a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-3275-560048032755630 TABLET, FILM COATED in 1 BOTTLE (0480-3275-56) 2024-02-13NoNoCurrent