HYPERRHO
- Product NDC
- 13533-661
- 11-digit product format
- 135330661
- Labeler code
- 13533
- Product ID
- 13533-661_cc33dfe9-295d-4ade-a303-6986d2fe190a
- 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
- 250 [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
- MINI-DOSE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN RHO(D) IMMUNE GLOBULIN | 250 [iU]/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13533-661-06 | HYPERRHO MINI-DOSE | 10 in 1 CARTON | SOLUTION | 10 | | 20 |
| 13533-661-60 | HYPERRHO MINI-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 |
|---|
| 13533-661 | HYPERRHO MINI-DOSE (RHO(D) IMMUNE GLOBULIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC] | 19 | Current NDC, Legacy NDC, 2 package rows | 20250523_b2ff5610-722c-523e-961d-668d60f82d9e.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 |
|---|
| 13533-661-06 | 13533066106 | 10 SYRINGE in 1 CARTON (13533-661-06) / 1 mL in 1 SYRINGE (13533-661-60) | 10 syringe | 1996-08-14 | 0000-00-00 | No | No | Current |
| 13533-661-60 | 13533066160 | 1 mL in 1 SYRINGE | 1 ml | | | | | Historical |