CNJ-016
- Product NDC
- 60492-0173
- 11-digit product format
- 604920173
- Labeler code
- 60492
- Product ID
- 60492-0173_ad4abcf6-88ca-41ff-a0f0-75692c8d517c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vaccinia Immune Globulin Intravenous (Human)
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Emergent BioSolutions Canada Inc.
- Application
- BLA125109
- Marketing category
- BLA
- Marketing start
- 2005-05-02
- Substance
- HUMAN VACCINIA VIRUS IMMUNE GLOBULIN
- Active strength
- 1 [iU]/mL
- Pharmacologic classes
- Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CNJ-016
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN VACCINIA VIRUS IMMUNE GLOBULIN | 1 [iU]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7UB4J759TD |
| Rxcui | 1922329, 1922334 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60492-0173-1 | CNJ-016 | 12 mL in 1 VIAL, SINGLE-USE | INJECTION | 12 | | 8 |
| 60492-0173-2 | CNJ-016 | 24 in 1 CARTON | INJECTION | 24 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60492-0173 | CNJ-016 (VACCINIA IMMUNE GLOBULIN (HUMAN)) INJECTION [EMERGENT BIOSOLUTIONS CANADA INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20190522_a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60492-0173-1 | 60492017301 | 12 mL in 1 VIAL, SINGLE-USE | 12 ml | | | | | Historical |
| 60492-0173-2 | 60492017302 | 24 VIAL, SINGLE-USE in 1 CARTON (60492-0173-2) / 12 mL in 1 VIAL, SINGLE-USE (60492-0173-1) | | 2018-01-12 | 0000-00-00 | No | No | Current |