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NDC 52709-1701-05 Odactra 6; 6 [arb'U]/1; [arb'U]/1 Details
Odactra 6; 6 [arb'U]/1; [arb'U]/1
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 FARINAE; DERMATOPHAGOIDES PTERONYSSINUS.
Product Information
| NDC | 52709-1701 |
|---|---|
| Product ID | 52709-1701_1e822337-6296-4aa4-94b2-479fd3d9f217 |
| Associated GPIs | 20109902220740 |
| GCN Sequence Number | 076750 |
| GCN Sequence Number Description | mite,D.farinae-D.pteronyssinus TAB SUBL 12 SQ-HDM SUBLINGUAL |
| HIC3 | W7W |
| HIC3 Description | ALLERGENIC EXTRACTS, THERAPEUTIC |
| GCN | 42527 |
| HICL Sequence Number | 034376 |
| HICL Sequence Number Description | ALLERGENIC EXTRACT, MITE-D.FARINAE-D.PTERONYSSINUS,STANDARD |
| Brand/Generic | Brand |
| Proprietary Name | Odactra |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DERMATOPHAGOIDES PTERONYSSINUS and DERMATOPHAGOIDES FARINAE |
| Product Type | STANDARDIZED ALLERGENIC |
| Dosage Form | TABLET |
| Route | SUBLINGUAL |
| Active Ingredient Strength | 6; 6 |
| Active Ingredient Units | [arb'U]/1; [arb'U]/1 |
| Substance Name | DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS |
| Labeler Name | ALK-Abello A S |
| Pharmaceutical Class | Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125592 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 52709-1701-05 (52709170105)
| NDC Package Code | 52709-1701-5 |
|---|---|
| Billing NDC | 52709170105 |
| Package | 1 BLISTER PACK in 1 CARTON (52709-1701-5) / 5 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2018-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |