MIX OF 5 STANDARDIZED GRASS POLLEN
- Product NDC
- 0268-8073
- 11-digit product format
- 002688073
- Labeler code
- 0268
- Product ID
- 0268-8073_f4170117-0559-46bb-a4fb-66138c6a9874
- Type
- STANDARDIZED ALLERGENIC
- Nonproprietary name
- AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- ALK-Abello, Inc.
- Application
- BLA103058
- Marketing category
- BLA
- Marketing start
- 1997-12-18
- Substance
- AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN
- Active strength
- 20000; 20000; 20000; 20000; 20000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL
- Pharmacologic classes
- Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MIX OF 5 STANDARDIZED GRASS POLLEN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AGROSTIS GIGANTEA POLLEN | 20000 [BAU]/mL |
| ANTHOXANTHUM ODORATUM POLLEN | 20000 [BAU]/mL |
| DACTYLIS GLOMERATA POLLEN | 20000 [BAU]/mL |
| PHLEUM PRATENSE POLLEN | 20000 [BAU]/mL |
| POA PRATENSIS POLLEN | 20000 [BAU]/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0268-8073-06 | MIX OF 5 STANDARDIZED GRASS POLLEN | 5.5 mL in 1 VIAL | INJECTION, SOLUTION | 5.5 | | 6 |
| 0268-8073-10 | MIX OF 5 STANDARDIZED GRASS POLLEN | 10.5 mL in 1 VIAL | INJECTION, SOLUTION | 10.5 | | 6 |
| 0268-8073-50 | MIX OF 5 STANDARDIZED GRASS POLLEN | 53 mL in 1 VIAL | INJECTION, SOLUTION | 53 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0268-8073 | MIX OF 5 STANDARDIZED GRASS POLLEN (AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN AND POA PRATENSIS POLLEN) INJECTION, SOLUTION MIX OF 6 STANDARDIZED GRASS POLLEN (AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN AND POA PRATENSIS POLLEN) INJECTION, SOLUTION MIX OF 7 STANDARDIZED GRASS POLLEN (AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, POA PRATENSIS POLLEN AND ANTHOXANTHUM ODORATUM POLLEN) INJECTION, SOLUTION MIDWEST MIX OF STANDARDIZED GRASS (AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN AND POA PRATENSIS POLLEN) INJECTION, SOLUTION GRASS MIX NUMBER 4-S (AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN AND POA PRATENSIS POLLEN) INJECTION, SOLUTION [ALK-ABELLO, INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20200715_77618828-d658-4f15-9500-a07ef11a0a0c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0268-8073-06 | 00268807306 | 5.5 mL in 1 VIAL (0268-8073-06) | 5.5 ml | 1997-12-18 | 0000-00-00 | No | No | Current |
| 0268-8073-10 | 00268807310 | 10.5 mL in 1 VIAL (0268-8073-10) | 10.5 ml | 1997-12-18 | 0000-00-00 | No | No | Current |
| 0268-8073-50 | 00268807350 | 53 mL in 1 VIAL (0268-8073-50) | 53 ml | 1997-12-18 | 0000-00-00 | No | No | Current |