Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 30 AU per mL
- Product NDC
- 65044-6693
- 11-digit product format
- 650446693
- Labeler code
- 65044
- Product ID
- 65044-6693_f47bdb36-0d77-467c-9384-d8b4582796a3
- Type
- STANDARDIZED ALLERGENIC
- Nonproprietary name
- Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 30 AU per mL
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRADERMAL
- Labeler
- Jubilant HollisterStier LLC
- Application
- BLA103871
- Marketing category
- BLA
- Marketing start
- 1988-05-26
- Marketing end
- 0000-00-00
- Substance
- DERMATOPHAGOIDES PTERONYSSINUS
- Active strength
- 30 [AU]/mL
- Pharmacologic 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]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 65044-6693 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 65044-6693 | 65044-6693-5 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 65044-6693-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 65044-6693-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 65044-6693-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 65044-6693-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 65044-6693-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 65044-6693-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 65044-6693-5 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 65044-6693-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 65044-6693-5 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 65044-6693-5 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 65044-6693-5 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 65044-6693-5 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|
| 65044-6693-5 | Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 30 AU per mL | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | 18 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65044-6693 | 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 | Legacy NDC, 1 package rows | 20250121_61c5f011-e393-4f9c-b65b-3c06d93baebd.zip |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103871 | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | Rx | 2026-07-01 |
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 | Status |
|---|---|---|---|---|
| 65044-6693-5 | 65044669305 | 5 mL in 1 VIAL | 5 ml | Historical |