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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ALVAIZ
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ELTROMBOPAG CHOLINE | 9 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | F9G8XE24IB |
| Rxcui | 2675187, 2675193, 2675195, 2675197, 2675199, 2675201, 2675203, 2675205 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 349df11e-99eb-4fff-8cd5-538adda21b14 | Product name | 3 | 20251110 |
| 4db6dd95-5e83-4752-b5e1-62f824423c50 | Product name | 1 | 20241217 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| fa996cde-a51d-4f68-1429-4f06c00a39f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0480-3273-56 | ALVAIZ | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0480-3273-56 | EA - Each | 0480-3273 | 0825b63d-801f-42ee-80a2-c8be1a74a6fa | 1 | 2024-03-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2675193 | Alvaiz 18 MG Oral Tablet | PSN | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675197 | Alvaiz 36 MG Oral Tablet | PSN | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675201 | Alvaiz 54 MG Oral Tablet | PSN | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675205 | Alvaiz 9 MG Oral Tablet | PSN | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675187 | eltrombopag 18 MG Oral Tablet | PSN | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675195 | eltrombopag 36 MG Oral Tablet | PSN | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675199 | eltrombopag 54 MG Oral Tablet | PSN | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675203 | eltrombopag 9 MG Oral Tablet | PSN | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675193 | eltrombopag 18 MG Oral Tablet [Alvaiz] | SBD | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675197 | eltrombopag 36 MG Oral Tablet [Alvaiz] | SBD | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675201 | eltrombopag 54 MG Oral Tablet [Alvaiz] | SBD | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675205 | eltrombopag 9 MG Oral Tablet [Alvaiz] | SBD | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675187 | eltrombopag 18 MG Oral Tablet | SCD | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675195 | eltrombopag 36 MG Oral Tablet | SCD | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675199 | eltrombopag 54 MG Oral Tablet | SCD | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675203 | eltrombopag 9 MG Oral Tablet | SCD | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675193 | Alvaiz 18 MG (as eltrombopag choline 22.2 MG) Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675193 | Alvaiz 18 MG Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675197 | Alvaiz 36 MG (as eltrombopag choline 44.4 MG) Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675197 | Alvaiz 36 MG Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675201 | Alvaiz 54 MG (eltrombopag choline 66.6 MG) Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675201 | Alvaiz 54 MG Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675205 | Alvaiz 9 MG (as eltrombopag choline 11.1 MG) Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675205 | Alvaiz 9 MG Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675187 | eltrombopag 18 MG (as eltrombopag choline 22.2 MG) Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675195 | eltrombopag 36 MG (as eltrombopag choline 44.4 MG) Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675199 | eltrombopag 54 MG (as eltrombopag choline 66.6 MG) Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
| 2675203 | eltrombopag 9 MG (as eltrombopag choline 11.1 MG) Oral Tablet | SY | ed51e463-7a03-4858-bbd2-882ce4753d5a | 7 |
Packages#
| 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 |