NDC 36987-2548
Black Birch
Black Birch
Black 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 Lenta Pollen.
| Product ID | 36987-2548_69cd05e6-a993-428b-9b0c-0235126ba63b |
| NDC | 36987-2548 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Black Birch |
| Generic Name | Black 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 LENTA POLLEN |
| Active Ingredient Strength | 0 g/mL |
| Pharm Classes | Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased IgG Production [PE],Pollen [CS],Allergens [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 36987-2548-3
30 mL in 1 VIAL, MULTI-DOSE (36987-2548-3)
| Marketing Start Date | 1972-08-29 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 36987-2548-3 [36987254803]
Black 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 36987-2548-1 [36987254801]
Black 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 36987-2548-4 [36987254804]
Black 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 36987-2548-2 [36987254802]
Black 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 LENTA POLLEN | .1 g/mL |
OpenFDA Data
Pharmacological Class
- Increased Histamine Release [PE]
- Cell-mediated Immunity [PE]
- Non-Standardized Pollen Allergenic Extract [EPC]
- Increased IgG Production [PE]
- Pollen [CS]
- Allergens [CS]
NDC Crossover Matching brand name "Black Birch" or generic name "Black Birch"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 36987-2541 | Black Birch | Black Birch |
| 36987-2542 | Black Birch | Black Birch |
| 36987-2543 | Black Birch | Black Birch |
| 36987-2544 | Black Birch | Black Birch |
| 36987-2545 | Black Birch | Black Birch |
| 36987-2546 | Black Birch | Black Birch |
| 36987-2547 | Black Birch | Black Birch |
| 36987-2548 | Black Birch | Black Birch |
| 49288-0626 | Black Birch | Black Birch |
| 0268-6608 | BETULA LENTA POLLEN | Black Birch |
| 0268-6686 | BETULA LENTA POLLEN | Black Birch |
Trademark Results [Black Birch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BLACK BIRCH 88898688 not registered Live/Pending |
Cintron, Eduardo 2020-05-03 |
 BLACK BIRCH 85253972 not registered Dead/Abandoned |
The New Zealand Wine Company Limited 2011-02-28 |
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