NDC 52709-1701
Odactra
Dermatophagoides Pteronyssinus And Dermatophagoides Farinae
Odactra is a Sublingual Tablet in the Standardized Allergenic category. It is labeled and distributed by Alk-abello A S. The primary component is Dermatophagoides Pteronyssinus; Dermatophagoides Farinae.
| Product ID | 52709-1701_0b7229a0-4606-42a6-aabb-0de8f5a9c0dd |
| NDC | 52709-1701 |
| Product Type | Standardized Allergenic |
| Proprietary Name | Odactra |
| Generic Name | Dermatophagoides Pteronyssinus And Dermatophagoides Farinae |
| Dosage Form | Tablet |
| Route of Administration | SUBLINGUAL |
| Marketing Start Date | 2018-01-01 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125592 |
| Labeler Name | ALK-Abello A S |
| Substance Name | DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE |
| Active Ingredient Strength | 6 [arb'U]/1; [arb'U]/1 |
| Pharm Classes | Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 52709-1701-3
3 BLISTER PACK in 1 CARTON (52709-1701-3) > 10 TABLET in 1 BLISTER PACK (52709-1701-1)
| Marketing Start Date | 2018-01-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 52709-1701-1 [52709170101]
Odactra TABLET
| Marketing Category | BLA |
| Application Number | BLA125592 |
| Product Type | STANDARDIZED ALLERGENIC |
| Billing Unit | EA |
| Marketing Start Date | 2018-01-01 |
NDC 52709-1701-3 [52709170103]
Odactra TABLET
| Marketing Category | BLA |
| Application Number | BLA125592 |
| Product Type | STANDARDIZED ALLERGENIC |
| Billing Unit | EA |
| Marketing Start Date | 2018-01-01 |
NDC 52709-1701-5 [52709170105]
Odactra TABLET
| Marketing Category | BLA |
| Application Number | BLA125592 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 2018-01-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| DERMATOPHAGOIDES PTERONYSSINUS | 6 [arb'U]/1 |
Pharmacological Class
- Standardized Insect Allergenic Extract [EPC]
- Increased Histamine Release [PE]
- Cell-mediated Immunity [PE]
- Increased IgG Production [PE]
- Antigens
- Dermatophagoides [CS]
- Insect Proteins [CS]
- Allergens [CS]
- Allergens [CS]
- Insect Proteins [CS]
- Standardized Insect Allergenic Extract [EPC]
- Increased Histamine Release [PE]
- Cell-mediated Immunity [PE]
- Increased IgG Production [PE]
- Antigens
- Dermatophagoides [CS]
Trademark Results [Odactra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ODACTRA 86821128 5387196 Live/Registered |
ALK-ABELLÃ A/S 2015-11-16 |
 ODACTRA 77737096 3955335 Dead/Cancelled |
MERCK SHARP & DOHME CORP. 2009-05-14 |
 ODACTRA 76635194 not registered Dead/Abandoned |
Merck & Co., Inc. 2005-04-05 |
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