Rhophylac
- Product NDC
- 44206-300
- 11-digit product format
- 442060300
- Labeler code
- 44206
- Product ID
- 44206-300_32c1f783-bd20-45bc-98d8-cdd5efa9f0d6
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- HUMAN RHO(D) IMMUNE GLOBULIN
- Dosage form
- SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- CSL Behring AG
- Application
- BLA125070
- Marketing category
- BLA
- Marketing start
- 2009-01-06
- Substance
- HUMAN RHO(D) IMMUNE GLOBULIN
- Active strength
- 1500 [iU]/2mL
- Pharmacologic classes
- Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rhophylac
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN RHO(D) IMMUNE GLOBULIN | 1500 [iU]/2mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 44206-300-01 | Rhophylac | 1 in 1 CARTON | SOLUTION | 1 | | 15 |
| 44206-300-10 | Rhophylac | 10 in 1 CARTON | SOLUTION | 10 | | 15 |
| 44206-300-90 | Rhophylac | 2 mL in 1 SYRINGE, GLASS | SOLUTION | 2 | | 15 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44206-300 | RHOPHYLAC (HUMAN RHO(D) IMMUNE GLOBULIN) SOLUTION [CSL BEHRING AG] | 14 | Current NDC, Legacy NDC, 3 package rows | 20210211_c1b5d801-336f-4541-a7d9-a8d4a110a4cc.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 |
|---|
| 44206-300-01 | 44206030001 | 1 SYRINGE, GLASS in 1 CARTON (44206-300-01) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) | | 2009-01-06 | 0000-00-00 | No | No | Current |
| 44206-300-10 | 44206030010 | 10 SYRINGE, GLASS in 1 CARTON (44206-300-10) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) | | 2009-01-06 | 0000-00-00 | No | No | Current |
| 44206-300-90 | 44206030090 | 2 mL in 1 SYRINGE, GLASS | 2 ml | | | | | Historical |