Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL
- Product NDC
- 65044-6695
- 11-digit product format
- 650446695
- Labeler code
- 65044
- Product ID
- 65044-6695_c0f7a73d-257f-46e9-b52d-ec3758576b4b
- Type
- STANDARDIZED ALLERGENIC
- Nonproprietary name
- Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Jubilant HollisterStier LLC
- Application
- BLA103871
- Marketing category
- BLA
- Marketing start
- 1988-05-26
- Substance
- DERMATOPHAGOIDES PTERONYSSINUS
- Active strength
- 10000 [AU]/mL
- Pharmacologic classes
- Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DERMATOPHAGOIDES PTERONYSSINUS | 10000 [AU]/mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65044-6695-2 | Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | 18 | |
| 65044-6695-3 | Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL | 30 mL in 1 VIAL | INJECTION, SOLUTION | 30 | 18 | |
| 65044-6695-4 | Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | 18 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65044-6695 | STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 10000 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 30000 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 30 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 300 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, BULK, 10000 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, SCRATCH OR BULK, 30000 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 30 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 300 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, BULK, 10000 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, SCRATCH OR BULK, 30000 AU PER ML INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER | 16 | Current NDC, Legacy NDC, 3 package rows | 20250121_61c5f011-e393-4f9c-b65b-3c06d93baebd.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1192764 | American house dust mite allergenic extract 15,000 AU/mL / European house dust mite allergenic extract 15,000 AU/mL Injectable Solution | PSN | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 852825 | American house dust mite extract 10000 AU/ML Injectable Solution | PSN | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854046 | American house dust mite extract 30 AU/ML Injectable Solution | PSN | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854050 | American house dust mite extract 300 AU/ML Injectable Solution | PSN | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854052 | American house dust mite extract 30000 AU/ML Injectable Solution | PSN | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 1192787 | Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable Solution | PSN | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 852829 | European house dust mite extract 10000 AU/ML Injectable Solution | PSN | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854071 | European house dust mite extract 30 AU/ML Injectable Solution | PSN | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854066 | European house dust mite extract 300 AU/ML Injectable Solution | PSN | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854068 | European house dust mite extract 30000 AU/ML Injectable Solution | PSN | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 852825 | American house dust mite allergenic extract 10000 AU/ML Injectable Solution | SCD | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 1192764 | American house dust mite allergenic extract 15000 AU/ML / European house dust mite allergenic extract 15000 AU/ML Injectable Solution | SCD | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854046 | American house dust mite allergenic extract 30 AU/ML Injectable Solution | SCD | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854050 | American house dust mite allergenic extract 300 AU/ML Injectable Solution | SCD | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854052 | American house dust mite allergenic extract 30000 AU/ML Injectable Solution | SCD | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 1192787 | American house dust mite allergenic extract 5000 AU/ML / European house dust mite allergenic extract 5000 AU/ML Injectable Solution | SCD | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 852829 | European house dust mite allergenic extract 10000 AU/ML Injectable Solution | SCD | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854071 | European house dust mite allergenic extract 30 AU/ML Injectable Solution | SCD | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854066 | European house dust mite allergenic extract 300 AU/ML Injectable Solution | SCD | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854068 | European house dust mite allergenic extract 30000 AU/ML Injectable Solution | SCD | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 1192764 | American house dust mite extract 15,000 AU/ML / European house dust mite extract 15,000 AU/ML Injectable Solution | SY | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 852825 | Dermatophagoides farinae extract 10,000 AU/ML Injectable Solution | SY | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 1192764 | Dermatophagoides farinae extract 15,000 AU/ML / Dermatophagoides pteronyssinus extract 15,000 AU/ML Injectable Solution | SY | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854046 | Dermatophagoides farinae extract 30 AU/ML Injectable Solution | SY | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854052 | Dermatophagoides farinae extract 30,000 AU/ML Injectable Solution | SY | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854050 | Dermatophagoides farinae extract 300 AU/ML Injectable Solution | SY | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 1192787 | Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable Solution | SY | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 852829 | Dermatophagoides pteronyssinus extract 10,000 AU/ML Injectable Solution | SY | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854071 | Dermatophagoides pteronyssinus extract 30 AU/ML Injectable Solution | SY | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854068 | Dermatophagoides pteronyssinus extract 30,000 AU/ML Injectable Solution | SY | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
| 854066 | Dermatophagoides pteronyssinus extract 300 AU/ML Injectable Solution | SY | 61c5f011-e393-4f9c-b65b-3c06d93baebd | 18 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65044-6695-2 | 65044669502 | 10 mL in 1 VIAL (65044-6695-2) | 10 ml | 1988-05-26 | 0000-00-00 | No | No | Current |
| 65044-6695-3 | 65044669503 | 30 mL in 1 VIAL (65044-6695-3) | 30 ml | 1988-05-26 | 0000-00-00 | No | No | Current |
| 65044-6695-4 | 65044669504 | 50 mL in 1 VIAL (65044-6695-4) | 50 ml | 1988-05-26 | 0000-00-00 | No | No | Current |