NDC 36987-2549
White Birch
White Birch
White Birch is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Betula Populifolia Pollen.
| Product ID | 36987-2549_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b |
| NDC | 36987-2549 |
| Product Type | Human Prescription Drug |
| Proprietary Name | White Birch |
| Generic Name | White Birch |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRADERMAL; SUBCUTANEOUS |
| Marketing Start Date | 1972-08-29 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102192 |
| Labeler Name | Nelco Laboratories, Inc. |
| Substance Name | BETULA POPULIFOLIA POLLEN |
| Active Ingredient Strength | 10000 [PNU]/mL |
| Pharm Classes | 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 | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 36987-2549-4
50 mL in 1 VIAL, MULTI-DOSE (36987-2549-4)
| Marketing Start Date | 1972-08-29 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 36987-2549-1 [36987254901]
White Birch INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-2549-2 [36987254902]
White Birch INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-2549-4 [36987254904]
White Birch INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-2549-3 [36987254903]
White Birch INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| BETULA POPULIFOLIA POLLEN | 10000 [PNU]/mL |
OpenFDA Data
Pharmacological Class
- Non-Standardized Pollen Allergenic Extract [EPC]
- Increased Histamine Release [PE]
- Cell-mediated Immunity [PE]
- Increased IgG Production [PE]
- Pollen [CS]
- Allergens [CS]
NDC Crossover Matching brand name "White Birch" or generic name "White Birch"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 36987-2549 | White Birch | White Birch |
| 36987-2550 | White Birch | White Birch |
| 36987-2551 | White Birch | White Birch |
| 36987-2552 | White Birch | White Birch |
| 36987-2553 | White Birch | White Birch |
| 36987-2554 | White Birch | White Birch |
| 36987-2555 | White Birch | White Birch |
| 36987-2556 | White Birch | White Birch |
| 49288-0080 | White Birch | White Birch |
| 0268-6610 | BETULA LENTA POLLEN | White Birch |
| 0268-6688 | BETULA LENTA POLLEN | White Birch |
Trademark Results [White Birch]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.