MICRhoGAM Ultra-Filtered PLUS
- Product NDC
- 0562-7806
- 11-digit product format
- 005627806
- Labeler code
- 0562
- Product ID
- 0562-7806_fd670401-c911-45aa-a41f-b243d30800c1
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- HUMAN RHO(D) IMMUNE GLOBULIN
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Kedrion Biopharma Inc
- Application
- BLA103777
- Marketing category
- BLA
- Marketing start
- 2007-03-09
- Marketing end
- 0000-00-00
- Substance
- HUMAN RHO(D) IMMUNE GLOBULIN
- Active strength
- 50 ug/1
- Pharmacologic classes
- Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0562-7806-00 | MICRhoGAM Ultra-Filtered PLUS | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | 19 | |
| 0562-7806-01 | MICRhoGAM Ultra-Filtered PLUS | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 19 | |
| 0562-7806-05 | MICRhoGAM Ultra-Filtered PLUS | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | 19 | |
| 0562-7806-25 | MICRhoGAM Ultra-Filtered PLUS | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0562-7806-00 | EA - Each | 0562-7806 | 2053adf0-ccf1-426a-ab11-31264df18598 | 1 | 2014-02-04 |
| 0562-7806-01 | EA - Each | 0562-7806 | 42899d5c-8323-444c-974f-c291b4721fed | 1 | 2012-07-24 |
| 0562-7806-05 | EA - Each | 0562-7806 | ae316482-2490-47ee-8b02-8da135b27037 | 1 | 2012-07-24 |
| 0562-7806-25 | EA - Each | 0562-7806 | ecb11afd-ba62-4851-9f38-7c68c2343682 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0562-7806 | RHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION BIOPHARMA INC] | 18 | Legacy NDC, 4 package rows | 20250101_d87e4d0b-2442-4135-b3f9-5c4f74845b87.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 731380 | MICRhoGAM 250 UNT (50 MCG) Prefilled Syringe | PSN | d87e4d0b-2442-4135-b3f9-5c4f74845b87 | 19 |
| 731381 | rho(D) immune globulin, human 1500 UNT (300 MCG) Prefilled Syringe | PSN | d87e4d0b-2442-4135-b3f9-5c4f74845b87 | 19 |
| 1790353 | rho(D) immune globulin, human 250 UNT (50 MCG) Prefilled Syringe | PSN | d87e4d0b-2442-4135-b3f9-5c4f74845b87 | 19 |
| 731383 | RhoGAM 1500 UNT (300 MCG) Prefilled Syringe | PSN | d87e4d0b-2442-4135-b3f9-5c4f74845b87 | 19 |
| 731383 | Rho(D) immune globulin, human 1500 UNT Prefilled Syringe [RhoGAM] | SBD | d87e4d0b-2442-4135-b3f9-5c4f74845b87 | 19 |
| 731380 | Rho(D) immune globulin, human 250 UNT Prefilled Syringe [MICRhoGAM] | SBD | d87e4d0b-2442-4135-b3f9-5c4f74845b87 | 19 |
| 731381 | Rho(D) immune globulin, human 1500 UNT Prefilled Syringe | SCD | d87e4d0b-2442-4135-b3f9-5c4f74845b87 | 19 |
| 1790353 | Rho(D) immune globulin, human 250 UNT Prefilled Syringe | SCD | d87e4d0b-2442-4135-b3f9-5c4f74845b87 | 19 |
| 731380 | MICRhoGAM 250 UNT Prefilled Syringe | SY | d87e4d0b-2442-4135-b3f9-5c4f74845b87 | 19 |
| 731383 | RhoGAM 1500 UNT Prefilled Syringe | SY | d87e4d0b-2442-4135-b3f9-5c4f74845b87 | 19 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0562-7806-00 | 00562780600 | 1 in 1 POUCH | Historical | |||||
| 0562-7806-01 | 00562780601 | 1 POUCH in 1 CARTON (0562-7806-01) > 1 INJECTION, SOLUTION in 1 POUCH (0562-7806-00) | 1 pouch | 2007-03-09 | 0000-00-00 | No | No | Current |
| 0562-7806-05 | 00562780605 | 5 POUCH in 1 CARTON (0562-7806-05) > 1 INJECTION, SOLUTION in 1 POUCH (0562-7806-00) | 5 pouch | 2007-03-09 | 0000-00-00 | No | No | Current |
| 0562-7806-25 | 00562780625 | 25 POUCH in 1 CARTON (0562-7806-25) > 1 INJECTION, SOLUTION in 1 POUCH (0562-7806-00) | 25 pouch | 2007-03-09 | 0000-00-00 | No | No | Current |