5 GRASS MIX is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Phleum Pratense; Dactylis Glomerata; Poa Pratensis; Agrostis Gigantea Pollen; Anthoxanthum Odoratum.
| Product ID | 0268-8008_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d |
| NDC | 0268-8008 |
| Product Type | Non-standardized Allergenic |
| Proprietary Name | 5 GRASS MIX |
| Generic Name | Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Phleum Pratense, Poa Pratensis |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 1975-01-15 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103753 |
| Labeler Name | ALK-Abello, Inc. |
| Substance Name | PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM |
| Active Ingredient Strength | 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL |
| Pharm Classes | Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 1975-01-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA103753 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1975-01-15 |
| Marketing Category | BLA |
| Application Number | BLA103753 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1975-01-15 |
| Ingredient | Strength |
|---|---|
| PHLEUM PRATENSE | 10000 [PNU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-8005 | 5 GRASS MIX | PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN |
| 0268-8006 | 5 GRASS MIX | PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN |
| 0268-8007 | 5 GRASS MIX | PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN |
| 0268-8008 | 5 GRASS MIX | AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, PHLEUM PRATENSE, POA PRATENSIS |
| 0268-8009 | 5 GRASS MIX | AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, PHLEUM PRATENSE, POA PRATENSIS |
| 0268-8010 | 5 GRASS MIX | PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN |