HYPERRHO
- Product NDC
- 13533-631
- 11-digit product format
- 135330631
- Labeler code
- 13533
- Product ID
- 13533-631_15eb46ca-9bb5-4d31-afb8-ba54f07d8f1e
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- RHO(D) IMMUNE GLOBULIN (HUMAN)
- Dosage form
- SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- GRIFOLS USA, LLC
- Application
- BLA101141
- Marketing category
- BLA
- Marketing start
- 1996-08-14
- Substance
- HUMAN RHO(D) IMMUNE GLOBULIN
- Active strength
- 1500 [iU]/mL
- 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
- HYPERRHO
- Brand name suffix
- FULL DOSE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN RHO(D) IMMUNE GLOBULIN | 1500 [iU]/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13533-631-02 | HYPERRHO FULL DOSE | 1 in 1 CARTON | SOLUTION | 1 | | 20 |
| 13533-631-03 | HYPERRHO FULL DOSE | 1 in 1 CARTON | SOLUTION | 1 | | 20 |
| 13533-631-11 | HYPERRHO FULL DOSE | 10 in 1 CARTON | SOLUTION | 10 | | 20 |
| 13533-631-20 | HYPERRHO FULL DOSE | 1 mL in 1 SYRINGE | SOLUTION | 1 | | 20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13533-631 | HYPERRHO FULL DOSE (RHO(D) IMMUNE GLOBULIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC] | 19 | Current NDC, Legacy NDC, 4 package rows | 20250523_5bfc342e-8dc2-9344-0bd3-09c45a06af99.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 |
|---|
| 13533-631-02 | 13533063102 | 1 SYRINGE in 1 CARTON (13533-631-02) / 1 mL in 1 SYRINGE (13533-631-20) | 1 syringe | 1996-08-14 | 0000-00-00 | No | No | Current |
| 13533-631-03 | 13533063103 | 1 in 1 CARTON | | | | | | Historical |
| 13533-631-11 | 13533063111 | 10 CARTON in 1 CARTON (13533-631-11) / 1 SYRINGE in 1 CARTON (13533-631-03) / 1 mL in 1 SYRINGE (13533-631-20) | 10 carton | 1996-08-14 | 0000-00-00 | No | No | Current |
| 13533-631-20 | 13533063120 | 1 mL in 1 SYRINGE | 1 ml | | | | | Historical |