ALVAIZ
- Product NDC
- 0480-3276
- 11-digit product format
- 004803276
- Labeler code
- 0480
- Product ID
- 0480-3276_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
- 54 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
Orange Book products#
| 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#
| 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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | d06236e962d9… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N216774-001 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-001 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-001 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-002 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-002 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-002 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-003 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-003 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-003 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-004 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-004 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-004 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-001 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-001 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-001 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-002 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-002 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-002 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-003 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-003 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-003 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-004 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-004 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-004 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-001 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-001 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-001 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-002 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-002 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-002 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-003 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-003 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-003 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-004 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-004 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-004 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-001 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-001 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-001 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-002 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | fd3edfee7708… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ALVAIZ
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ELTROMBOPAG CHOLINE | 54 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F9G8XE24IB | Internal UNII lookup |
Harmonized RxCUI identifiers#
| 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#
| Identifier | FDA.report destination |
|---|---|
| ed51e463-7a03-4858-bbd2-882ce4753d5a | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 0480-3276-56 | 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 |
|---|---|---|---|---|---|
| 0480-3276-56 | EA - Each | 0480-3276 | fdacc8cf-dbfa-4433-bd7d-5cce909b55f9 | 1 | 2024-03-12 |
DailyMed Dashboard NDC Coverage#
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.
| 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 | 216774 NDA216774 0480-3276 |
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 |
|---|---|---|---|---|---|---|
| 0480-3276-56 | 00480327656 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-3276-56) | 2024-02-13 | No | No | Current |