OGIVRI
- Product NDC
- 67457-847
- 11-digit product format
- 674570847
- Labeler code
- 67457
- Product ID
- 67457-847_b57e61b9-04b7-4d8b-b7c2-be56a060421b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- trastuzumab
- Dosage form
- KIT
- Labeler
- Mylan Institutional LLC
- Application
- BLA761074
- Marketing category
- BLA
- Marketing start
- 2019-11-29
- Marketing end
- 2027-04-30
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OGIVRI
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| bd11614e-4776-4a92-aaca-2bcbb5f710ed | Product name | 1 | 20210115 |
| b914e981-d6dc-4748-bd51-accd6b85b817 | Product name | 1 | 20190618 |
| 9397f6d4-17a1-42b4-beda-fa2c0ea40c8c | Product name | 1 | 20190610 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67457-845-50 | OGIVRI | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 mL | 420 mg in 20mL | 15 |
| 67457-847-44 | OGIVRI | 1 in 1 CARTON | KIT | 1 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67457-847-44 | EA - Each | 67457-847 | 39eec129-14bf-4442-9b0a-65c5b886e9b1 | 1 | 2019-11-12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67457-847 | OGIVRI (TRASTUZUMAB-DKST) KIT OGIVRI (TRASTUZUMAB-DKST) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 15 | Current NDC, Legacy NDC, 2 package rows | 20240110_6b7938e6-14c7-4a65-9605-967542ecfb8f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2179758 | OGIVRI 150 MG Injection | PSN | 6b7938e6-14c7-4a65-9605-967542ecfb8f | 15 |
| 2179763 | OGIVRI 420 MG in 20 ML Injectable Solution | PSN | 6b7938e6-14c7-4a65-9605-967542ecfb8f | 15 |
| 2179753 | trastuzumab-dkst 150 MG Injection | PSN | 6b7938e6-14c7-4a65-9605-967542ecfb8f | 15 |
| 2179760 | trastuzumab-dkst 21 MG/ML Injectable Solution | PSN | 6b7938e6-14c7-4a65-9605-967542ecfb8f | 15 |
| 2179758 | trastuzumab-dkst 150 MG Injection [Ogivri] | SBD | 6b7938e6-14c7-4a65-9605-967542ecfb8f | 15 |
| 2179763 | trastuzumab-dkst 21 MG/ML Injectable Solution [Ogivri] | SBD | 6b7938e6-14c7-4a65-9605-967542ecfb8f | 15 |
| 2179753 | trastuzumab-dkst 150 MG Injection | SCD | 6b7938e6-14c7-4a65-9605-967542ecfb8f | 15 |
| 2179760 | trastuzumab-dkst 21 MG/ML Injectable Solution | SCD | 6b7938e6-14c7-4a65-9605-967542ecfb8f | 15 |
| 2179758 | Ogivri 150 MG Injection | SY | 6b7938e6-14c7-4a65-9605-967542ecfb8f | 15 |
| 2179763 | Ogivri 21 MG/ML Injectable Solution | SY | 6b7938e6-14c7-4a65-9605-967542ecfb8f | 15 |
| 2179763 | Ogivri 420 MG per 20 ML Injectable Solution | SY | 6b7938e6-14c7-4a65-9605-967542ecfb8f | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67457-845-50 | 67457084550 | 20 mL in 1 VIAL, MULTI-DOSE | 20 ml | Historical | ||||
| 67457-847-44 | 67457084744 | 1 KIT in 1 CARTON (67457-847-44) * 20 mL in 1 VIAL, MULTI-DOSE (67457-845-50) * 20 mL in 1 VIAL (67457-846-20) | 1 kit | 2019-11-29 | 2027-04-30 | No | No | Current |