OGIVRI
- Product NDC
- 83257-004
- 11-digit product format
- 832570004
- Labeler code
- 83257
- Product ID
- 83257-004_ef07d382-d369-dfad-1491-3a4cc3b57d01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- trastuzumab-dkst
- Dosage form
- KIT
- Labeler
- Biocon Biologics Inc.
- Application
- BLA761074
- Marketing category
- BLA
- Marketing start
- 2023-10-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OGIVRI
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | P188ANX8CK |
| Rxcui | 2179753, 2179758, 2179760, 2179763 |
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 |
|---|---|---|---|---|---|---|
| 83257-003-11 | OGIVRI | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 mL | 420 mg in 20mL | 14 |
| 83257-004-12 | OGIVRI | 1 in 1 CARTON | KIT | 1 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83257-004-12 | EA - Each | 83257-004 | dad41144-5018-4c2a-97c1-e5f69ae55fcf | 1 | 2023-10-16 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83257-004 | OGIVRI (TRASTUZUMAB-DKST) KIT OGIVRI (TRASTUZUMAB-DKST) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BIOCON BIOLOGICS INC.] | 14 | Current NDC, 2 package rows | 20241212_b6465b44-a6dd-f99c-d009-6851cf05169c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2179758 | OGIVRI 150 MG Injection | PSN | b6465b44-a6dd-f99c-d009-6851cf05169c | 14 |
| 2179763 | OGIVRI 420 MG in 20 ML Injectable Solution | PSN | b6465b44-a6dd-f99c-d009-6851cf05169c | 14 |
| 2179753 | trastuzumab-dkst 150 MG Injection | PSN | b6465b44-a6dd-f99c-d009-6851cf05169c | 14 |
| 2179760 | trastuzumab-dkst 21 MG/ML Injectable Solution | PSN | b6465b44-a6dd-f99c-d009-6851cf05169c | 14 |
| 2179758 | trastuzumab-dkst 150 MG Injection [Ogivri] | SBD | b6465b44-a6dd-f99c-d009-6851cf05169c | 14 |
| 2179763 | trastuzumab-dkst 21 MG/ML Injectable Solution [Ogivri] | SBD | b6465b44-a6dd-f99c-d009-6851cf05169c | 14 |
| 2179753 | trastuzumab-dkst 150 MG Injection | SCD | b6465b44-a6dd-f99c-d009-6851cf05169c | 14 |
| 2179760 | trastuzumab-dkst 21 MG/ML Injectable Solution | SCD | b6465b44-a6dd-f99c-d009-6851cf05169c | 14 |
| 2179758 | Ogivri 150 MG Injection | SY | b6465b44-a6dd-f99c-d009-6851cf05169c | 14 |
| 2179763 | Ogivri 21 MG/ML Injectable Solution | SY | b6465b44-a6dd-f99c-d009-6851cf05169c | 14 |
| 2179763 | Ogivri 420 MG per 20 ML Injectable Solution | SY | b6465b44-a6dd-f99c-d009-6851cf05169c | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83257-003-11 | 83257000311 | 20 mL in 1 VIAL, MULTI-DOSE | 20 ml | Historical | |||
| 83257-004-12 | 83257000412 | 1 KIT in 1 CARTON (83257-004-12) * 20 mL in 1 VIAL, MULTI-DOSE (83257-003-11) * 20 mL in 1 VIAL (83257-002-11) | 1 kit | 2023-10-01 | No | No | Current |