Mixture of Standardized Mites
- Product NDC
- 49288-0182
- 11-digit product format
- 492880182
- Labeler code
- 49288
- Product ID
- 49288-0182_745162a9-2fdc-4b03-a3bc-32d410b3d9c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mixture of Standardized Mites
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRADERMAL; SUBCUTANEOUS
- Labeler
- Antigen Laboratories, Inc.
- Application
- BLA102225
- Marketing category
- BLA
- Marketing start
- 1991-10-22
- Marketing end
- 0000-00-00
- Substance
- DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE
- Active strength
- 5000 [AU]/mL; [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],Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|
| 49288-0182-2 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d7a9-621f-e053-dbdaa90a74ad | Allergenic Extract |
| 49288-0182-3 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d7a9-621f-e053-dbdaa90a74ad | Allergenic Extract |
| 49288-0182-4 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d7a9-621f-e053-dbdaa90a74ad | Allergenic Extract |
| 49288-0182-5 | 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 |
|---|---|---|---|---|---|---|
| 49288-0182-2 | Mixture of Standardized Mites | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | 3 | |
| 49288-0182-3 | Mixture of Standardized Mites | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | 3 | |
| 49288-0182-4 | Mixture of Standardized Mites | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 30 | 3 | |
| 49288-0182-5 | Mixture of Standardized Mites | 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 |
|---|---|---|---|---|
| 49288-0182 | STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION MIXTURE OF STANDARDIZED MITES INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 3 | Legacy NDC, 4 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 |
|---|---|---|---|---|
| 49288-0182-2 | 49288018202 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | Historical |
| 49288-0182-3 | 49288018203 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | Historical |
| 49288-0182-4 | 49288018204 | 30 mL in 1 VIAL, MULTI-DOSE | 30 ml | Historical |
| 49288-0182-5 | 49288018205 | 50 mL in 1 VIAL, MULTI-DOSE | 50 ml | Historical |