Synagis
- Product NDC
- 66658-230
- 11-digit product format
- 666580230
- Labeler code
- 66658
- Product ID
- 66658-230_48e6af70-cd93-3f1d-e063-6394a90a8104
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- palivizumab
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Swedish Orphan Biovitrum AB (publ)
- Application
- BLA103770
- Marketing category
- BLA
- Marketing start
- 1999-12-09
- Marketing end
- 2026-09-30
- Substance
- PALIVIZUMAB
- Active strength
- 50 mg/.5mL
- Pharmacologic classes
- Antibodies, Monoclonal [CS], Fusion Protein Inhibitors [MoA], Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Synagis
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PALIVIZUMAB | 50 mg/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DQ448MW7KS |
| Rxcui | 1657341, 1657343, 1657361, 1657362 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66658-230-01 | Synagis | 0.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 0.5 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66658-230 | SYNAGIS (PALIVIZUMAB) INJECTION, SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 5 | Current NDC, Legacy NDC, 1 package rows | 20220329_3a0096c7-8139-44cd-bba4-520ab05c2cb2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66658-230-01 | 66658023001 | .5 mL in 1 VIAL, SINGLE-DOSE (66658-230-01) | 2005-09-28 | 2026-09-30 | No | No | Current |