5 GRASS MIX
- Product NDC
- 0268-8008
- 11-digit product format
- 002688008
- Labeler code
- 0268
- Product ID
- 0268-8008_3fd70615-c7a0-4144-a725-117e4579b25e
- Type
- NON-STANDARDIZED ALLERGENIC
- Nonproprietary name
- AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, PHLEUM PRATENSE, POA PRATENSIS
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- ALK-Abello, Inc.
- Application
- BLA103753
- Marketing category
- BLA
- Marketing start
- 1975-01-15
- Substance
- AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM; DACTYLIS GLOMERATA; PHLEUM PRATENSE; POA PRATENSIS
- Active strength
- 10000; 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], 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
- 5 GRASS MIX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AGROSTIS GIGANTEA POLLEN | 10000 [PNU]/mL |
| ANTHOXANTHUM ODORATUM | 10000 [PNU]/mL |
| DACTYLIS GLOMERATA | 10000 [PNU]/mL |
| PHLEUM PRATENSE | 10000 [PNU]/mL |
| POA PRATENSIS | 10000 [PNU]/mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0268-8008-10 | 5 GRASS MIX | 10.5 mL in 1 VIAL | INJECTION, SOLUTION | 10.5 | | 4 |
| 0268-8008-30 | 5 GRASS MIX | 32 mL in 1 VIAL | INJECTION, SOLUTION | 32 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0268-8008 | 5 GRASS MIX (PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN) INJECTION, SOLUTION 3 GRASS MIX (BROMUS INERMIS POLLEN, CYNODON DACTYLON, CYNODON DACTYLON) INJECTION, SOLUTION 4 WEED MIX (AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN) .......US AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN, ULMUS AMERICANA POLLEN) INJECTION, SOLUTION MIXED RAGWEED (AMBROSIA ARTEMISIIFOLIA, AMBROSIA TRIFIDA POLLEN) INJECTION, SOLUTION WESTERN WEED MIX (AMBROSIA ACANTHICARPA POLLEN, AMBROSIA PSILOSTACHYA POLLEN, ARTEMISIA TRIDENTATA POLLEN, BASSIA SCOPARIA POLLEN, SALSOLA KALI POLLEN) INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230527_edcb6de3-85d9-4acb-97c2-27fc67218d79.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0268-8008-10 | 00268800810 | 10.5 mL in 1 VIAL (0268-8008-10) | 10.5 ml | 1975-01-15 | 0000-00-00 | No | No | Current |
| 0268-8008-30 | 00268800830 | 32 mL in 1 VIAL (0268-8008-30) | 32 ml | 1975-01-15 | 0000-00-00 | No | No | Current |