Standardized Mite, Dermatophagoides pteronyssinus
- Product NDC
- 49288-0173
- 11-digit product format
- 492880173
- Labeler code
- 49288
- Product ID
- 49288-0173_745162a9-2fdc-4b03-a3bc-32d410b3d9c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Standardized Mite, Dermatophagoides pteronyssinus
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRADERMAL; SUBCUTANEOUS
- Labeler
- Antigen Laboratories, Inc.
- Application
- BLA102225
- Marketing category
- BLA
- Marketing start
- 1992-02-06
- Marketing end
- 0000-00-00
- Substance
- DERMATOPHAGOIDES PTERONYSSINUS
- Active strength
- 3000 [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
- E
- Listing certified through
- 2017-12-31
- 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 | 49288-0173 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 49288-0173 | 49288-0173-3 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 49288-0173 | 49288-0173-4 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 49288-0173 | 49288-0173-5 | I | Inactivated by FDA | 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 | 49288-0173-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49288-0173-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49288-0173-4 | 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 | 49288-0173-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49288-0173-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49288-0173-4 | 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 | 49288-0173-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49288-0173-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49288-0173-4 | 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 | 49288-0173-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49288-0173-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49288-0173-4 | 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 | 49288-0173-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49288-0173-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49288-0173-4 | 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 | 49288-0173-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49288-0173-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49288-0173-4 | 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 | 49288-0173-5 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49288-0173-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49288-0173-4 | 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 | 49288-0173-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49288-0173-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49288-0173-4 | 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 | 49288-0173-5 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49288-0173-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49288-0173-4 | 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 | 49288-0173-5 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49288-0173-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49288-0173-4 | 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 | 49288-0173-5 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 49288-0173-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 49288-0173-4 | 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 | 49288-0173-5 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49288-0173-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49288-0173-4 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 49288-0173-5 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 49288-0173-3 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 49288-0173-4 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 49288-0173-5 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 49288-0173-3 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 49288-0173-4 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 49288-0173-5 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 49288-0173-3 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 49288-0173-4 | 1332a3947898… | d4bfe170f9cd… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49288-0173-3 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d7a9-621f-e053-dbdaa90a74ad | Allergenic Extract |
| 49288-0173-4 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d7a9-621f-e053-dbdaa90a74ad | Allergenic Extract |
| 49288-0173-5 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d7a9-621f-e053-dbdaa90a74ad | Allergenic Extract |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49288-0173-3 | Standardized Mite, Dermatophagoides pteronyssinus | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | 3 | |
| 49288-0173-4 | Standardized Mite, Dermatophagoides pteronyssinus | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 30 | 3 | |
| 49288-0173-5 | Standardized Mite, Dermatophagoides pteronyssinus | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49288-0173 | STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION MIXTURE OF STANDARDIZED MITES INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 3 | Legacy NDC, 3 package rows | 20090917_3b3cb12c-65d3-46ab-9bac-82c569a76220.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 852825 | American house dust mite extract 10000 AU/ML Injectable Solution | PSN | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1014382 | American house dust mite extract 3000 AU/ML Injectable Solution | PSN | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 852813 | American house dust mite extract 5000 AU/ML Injectable Solution | PSN | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1192787 | Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable Solution | PSN | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 852829 | European house dust mite extract 10000 AU/ML Injectable Solution | PSN | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1014369 | European house dust mite extract 3000 AU/ML Injectable Solution | PSN | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1014384 | European house dust mite extract 5000 AU/ML Injectable Solution | PSN | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 852825 | American house dust mite allergenic extract 10000 AU/ML Injectable Solution | SCD | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1014382 | American house dust mite allergenic extract 3000 AU/ML Injectable Solution | SCD | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1192787 | American house dust mite allergenic extract 5000 AU/ML / European house dust mite allergenic extract 5000 AU/ML Injectable Solution | SCD | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 852813 | American house dust mite allergenic extract 5000 AU/ML Injectable Solution | SCD | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 852829 | European house dust mite allergenic extract 10000 AU/ML Injectable Solution | SCD | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1014369 | European house dust mite allergenic extract 3000 AU/ML Injectable Solution | SCD | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1014384 | European house dust mite allergenic extract 5000 AU/ML Injectable Solution | SCD | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 852825 | Dermatophagoides farinae extract 10,000 AU/ML Injectable Solution | SY | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1014382 | Dermatophagoides farinae extract 3,000 AU/ML Injectable Solution | SY | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1192787 | Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable Solution | SY | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 852813 | Dermatophagoides farinae extract 5000 AU/ML Injectable Solution | SY | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 852829 | Dermatophagoides pteronyssinus extract 10,000 AU/ML Injectable Solution | SY | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1014369 | Dermatophagoides pteronyssinus extract 3,000 AU/ML Injectable Solution | SY | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
| 1014384 | Dermatophagoides pteronyssinus extract 5,000 AU/ML Injectable Solution | SY | 3b3cb12c-65d3-46ab-9bac-82c569a76220 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 49288-0173-3 | 49288017303 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | Historical |
| 49288-0173-4 | 49288017304 | 30 mL in 1 VIAL, MULTI-DOSE | 30 ml | Historical |
| 49288-0173-5 | 49288017305 | 50 mL in 1 VIAL, MULTI-DOSE | 50 ml | Historical |