Odactra
- Product NDC
- 52709-1701
- 11-digit product format
- 527091701
- Labeler code
- 52709
- Product ID
- 52709-1701_121cd31d-047d-45cc-9053-d6056725e85e
- Type
- STANDARDIZED ALLERGENIC
- Nonproprietary name
- DERMATOPHAGOIDES PTERONYSSINUS and DERMATOPHAGOIDES FARINAE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- ALK-Abello A S
- Application
- BLA125592
- Marketing category
- BLA
- Marketing start
- 2018-01-01
- Substance
- DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS
- Active strength
- 6; 6 [arb'U]/1; [arb'U]/1
- Pharmacologic classes
- 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], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Odactra
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DERMATOPHAGOIDES FARINAE | 6 [arb'U]/1 |
| DERMATOPHAGOIDES PTERONYSSINUS | 6 [arb'U]/1 |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52709-1701 | ODACTRA (DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE) TABLET [ALK-ABELLO A S] | 18 | Current NDC, Legacy NDC, 4 package rows | 20250309_71ca220d-78d5-47d4-be84-8d6e844b24b3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52709-1701-1 | 52709170101 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 52709-1701-3 | 52709170103 | 3 BLISTER PACK in 1 CARTON (52709-1701-3) / 10 TABLET in 1 BLISTER PACK (52709-1701-1) | 3 blister pack | 2018-01-01 | 0000-00-00 | No | No | Current |
| 52709-1701-5 | 52709170105 | 1 BLISTER PACK in 1 CARTON (52709-1701-5) / 5 TABLET in 1 BLISTER PACK | 1 blister pack | 2018-01-01 | 0000-00-00 | No | No | Current |