Orris Root is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Iris Germanica Var. Florentina Root.
| Product ID | 49288-0344_3af4be6b-c022-4834-9006-f6cc8d8041da |
| NDC | 49288-0344 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Orris Root |
| Generic Name | Orris Root |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRADERMAL; SUBCUTANEOUS |
| Marketing Start Date | 1974-03-23 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102223 |
| Labeler Name | Antigen Laboratories, Inc. |
| Substance Name | IRIS GERMANICA VAR. FLORENTINA ROOT |
| Active Ingredient Strength | 0 g/mL |
| Pharm Classes | Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 1974-03-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
| Ingredient | Strength |
|---|---|
| IRIS GERMANICA VAR. FLORENTINA ROOT | .05 g/mL |
| SPL SET ID: | d71013ab-718c-4cb0-ae1a-31fdd6db8851 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 22840-1530 | Orris Root | Iris germanica |
| 22840-1531 | Orris Root | Iris germanica |
| 22840-5515 | Orris Root | Iris germanica |
| 36987-2234 | Orris Root | Orris Root |
| 36987-2235 | Orris Root | Orris Root |
| 36987-2236 | Orris Root | Orris Root |
| 36987-2237 | Orris Root | Orris Root |
| 49288-0343 | Orris Root | Orris Root |
| 49288-0344 | Orris Root | Orris Root |
| 49643-020 | Orris Root | Orris Root |
| 54575-272 | ORRIS ROOT | iris germanica var. florentina root |