NDC 36987-2553
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 | 36987-2553_2a72f629-5585-48e0-bd3f-7804035e57fb |
| NDC | 36987-2553 |
| 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 | 40000 [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 36987-2553-2
10 mL in 1 VIAL, MULTI-DOSE (36987-2553-2)
| Marketing Start Date | 1972-08-29 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 36987-2553-1 [36987255301]
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 36987-2553-2 [36987255302]
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 36987-2553-4 [36987255304]
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 36987-2553-3 [36987255303]
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 | 40000 [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]
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