STANDARDIZED MEADOW FESCUE GRASS POLLEN
- Product NDC
- 54575-092
- 11-digit product format
- 545750092
- Labeler code
- 54575
- Product ID
- 54575-092_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Festuca elatior pollen
- Dosage form
- INJECTION, SOLUTION
- Route
- PERCUTANEOUS; SUBCUTANEOUS
- Labeler
- Allergy Laboratories, Inc.
- Application
- BLA101381
- Marketing category
- BLA
- Marketing start
- 1997-05-29
- Marketing end
- 0000-00-00
- Substance
- FESTUCA PRATENSIS POLLEN
- Active strength
- 100000 [BAU]/mL
- Pharmacologic classes
- Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 54575-092 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 54575-092 | 54575-092-02 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 54575-092 | 54575-092-10 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 54575-092 | 54575-092-30 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 54575-092 | 54575-092-50 | D | Discontinued by firm | 2026-07-31 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54575-092-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c367-f424-e053-dadaa90a57ce | Standardized Grasses |
| 54575-092-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c367-f424-e053-dadaa90a57ce | Standardized Grasses |
| 54575-092-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c367-f424-e053-dadaa90a57ce | Standardized Grasses |
| 54575-092-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c367-f424-e053-dadaa90a57ce | Standardized Grasses |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54575-092-02 | STANDARDIZED MEADOW FESCUE GRASS POLLEN | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | 5 | |
| 54575-092-10 | STANDARDIZED MEADOW FESCUE GRASS POLLEN | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | 5 | |
| 54575-092-30 | STANDARDIZED MEADOW FESCUE GRASS POLLEN | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 30 | 5 | |
| 54575-092-50 | STANDARDIZED MEADOW FESCUE GRASS POLLEN | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54575-092 | STANDARDIZED BERMUDA GRASS POLLEN (CYNODON DACTYLON POLLEN) INJECTION, SOLUTION STANDARDIZED KENTUCKY BLUEGRASS POLLEN (POA PRATENSIS POLLEN) INJECTION, SOLUTION STANDARDIZED MEADOW FESCUE GRASS POLLEN (FESTUCA ELATIOR POLLEN) INJECTION, SOLUTION STANDARDIZED ORCHARD GRASS POLLEN (DACTYLIS GLOMERATA POLLEN) INJECTION, SOLUTION STANDARDIZED REDTOP GRASS POLLEN (AGROSTIS ALBA POLLEN) INJECTION, SOLUTION STANDARDIZED PERENNIAL RYEGRASS GRASS POLLEN (LOLIUM PERENNE POLLEN) INJECTION, SOLUTION STANDARDIZED SWEET VERNAL GRASS POLLEN (ANTHOXANTHUM ODORATUM POLLEN) INJECTION, SOLUTION STANDARDIZED TIMOTHY GRASS POLLEN (PHLEUM PRATENSE POLLEN) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.] | 5 | Legacy NDC, 4 package rows | 20100405_c5390880-3440-46f1-8fef-f1ff0bde6edb.zip |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 101381 | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | Disc | 2026-06-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 897496 | Bermuda grass pollen extract 10000 UNT/mL Injectable Suspension | PSN | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 853278 | Kentucky bluegrass pollen extract 100000 BAU/mL Injectable Solution | PSN | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 854054 | meadow fescue grass pollen extract 100000 BAU/ML Injectable Solution | PSN | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 853047 | orchard grass pollen extract 100000 BAU/ML Injectable Solution | PSN | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 853027 | perennial rye grass pollen extract 100000 BAU/ML Injectable Solution | PSN | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 851873 | redtop grass pollen extract 100000 BAU/ML Injectable Solution | PSN | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 854162 | sweet vernal grass pollen extract 100000 BAU/ML Injectable Solution | PSN | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 852157 | Timothy grass pollen extract 100000 BAU/mL Injectable Solution | PSN | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 897496 | Bermuda grass pollen extract 10000 UNT/ML Injectable Suspension | SCD | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 853278 | Kentucky bluegrass pollen extract 100000 BAU/ML Injectable Solution | SCD | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 854054 | meadow fescue grass pollen extract 100000 BAU/ML Injectable Solution | SCD | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 853047 | orchard grass pollen extract 100000 BAU/ML Injectable Solution | SCD | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 853027 | perennial rye grass pollen extract 100000 BAU/ML Injectable Solution | SCD | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 851873 | redtop grass pollen extract 100000 BAU/ML Injectable Solution | SCD | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 854162 | sweet vernal grass pollen extract 100000 BAU/ML Injectable Solution | SCD | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 852157 | Timothy grass pollen extract 100000 BAU/ML Injectable Solution | SCD | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 851873 | Agrostis gigantea pollen extract 100,000 BAU/ML Injectable Solution | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 854162 | Anthoxanthum odoratum grass pollen extract 100,000 BAU/ML Injectable Solution | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 897496 | Cynodon dactylon pollen extract 10,000 BAU/ML Injectable Suspension | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 897496 | Cynodon dactylon pollen extract 10,000 UNT/ML Injectable Suspension | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 853047 | Dactylis glomerata pollen extract 100,000 BAU/ML Injectable Solution | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 854054 | Festuca elatior grass pollen extract 100,000 BAU/ML Injectable Solution | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 854054 | Festuca pratensis grass pollen extract 100,000 BAU/ML Injectable Solution | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 853278 | June grass pollen extract 100,000 BAU/ML Injectable Solution | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 853027 | Lolium perenne grass pollen extract 100,000 BAU/ML Injectable Solution | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 854054 | Lolium pratense grass pollen extract 100,000 BAU/ML Injectable Solution | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 852157 | Phleum pratense grass pollen extract 100,000 BAU/ML Injectable Solution | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 853278 | Poa pratensis grass pollen extract 100,000 BAU/ML Injectable Solution | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
| 854054 | Schedonorus pratensis grass pollen extract 100,000 BAU/ML Injectable Solution | SY | c5390880-3440-46f1-8fef-f1ff0bde6edb | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 54575-092-02 | 54575009202 | 2 mL in 1 VIAL, MULTI-DOSE | 2 ml | Historical |
| 54575-092-10 | 54575009210 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | Historical |
| 54575-092-30 | 54575009230 | 30 mL in 1 VIAL, MULTI-DOSE | 30 ml | Historical |
| 54575-092-50 | 54575009250 | 50 mL in 1 VIAL, MULTI-DOSE | 50 ml | Historical |