7 GRASS MIX
- Product NDC
- 0268-8014
- 11-digit product format
- 002688014
- Labeler code
- 0268
- Product ID
- 0268-8014_fb07a9de-091d-494d-a237-dba963cea4e7
- Type
- NON-STANDARDIZED ALLERGENIC
- Nonproprietary name
- AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- ALK-Abello, Inc.
- Application
- BLA103753
- Marketing category
- BLA
- Marketing start
- 1975-01-15
- Marketing end
- 0000-00-00
- Substance
- PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS; LOLIUM PERENNE; ANTHOXANTHUM ODORATUM
- Active strength
- 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL
- Pharmacologic classes
- Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 0268-8014 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 0268-8014 | 0268-8014-10 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 0268-8014 | 0268-8014-30 | D | Discontinued by firm | 2026-10-05 |
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 | 0268-8014-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0268-8014-10 | 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 | 0268-8014-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0268-8014-10 | 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 | 0268-8014-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0268-8014-10 | 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 | 0268-8014-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0268-8014-10 | 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 | 0268-8014-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0268-8014-10 | 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 | 0268-8014-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0268-8014-10 | 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 | 0268-8014-30 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0268-8014-10 | 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 | 0268-8014-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0268-8014-10 | 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 | 0268-8014-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0268-8014-10 | 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 | 0268-8014-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0268-8014-10 | 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 | 0268-8014-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0268-8014-10 | 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 | 0268-8014-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0268-8014-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0268-8014-10 | 7 GRASS MIX | 10.5 mL in 1 VIAL | INJECTION, SOLUTION | 10.5 | 4 | |
| 0268-8014-30 | 7 GRASS MIX | 32 mL in 1 VIAL | INJECTION, SOLUTION | 32 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0268-8014 | 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 | Legacy NDC, 2 package rows | 20230527_edcb6de3-85d9-4acb-97c2-27fc67218d79.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1922788 | giant ragweed pollen extract 100 UNT/ML / short ragweed pollen extract 100 UNT/ML Injectable Solution | PSN | edcb6de3-85d9-4acb-97c2-27fc67218d79 | 4 |
| 1922790 | giant ragweed pollen extract 20000 UNT/ML / short ragweed pollen extract 20000 UNT/ML Injectable Solution | PSN | edcb6de3-85d9-4acb-97c2-27fc67218d79 | 4 |
| 1922788 | giant ragweed pollen extract 100 UNT/ML / short ragweed pollen extract 100 UNT/ML Injectable Solution | SCD | edcb6de3-85d9-4acb-97c2-27fc67218d79 | 4 |
| 1922790 | giant ragweed pollen extract 20000 UNT/ML / short ragweed pollen extract 20000 UNT/ML Injectable Solution | SCD | edcb6de3-85d9-4acb-97c2-27fc67218d79 | 4 |
| 1922788 | Ambrosia artemisiifolia pollen extract 100 PNU/ML / Ambrosia trifida pollen extract 100 PNU/ML Injectable Solution | SY | edcb6de3-85d9-4acb-97c2-27fc67218d79 | 4 |
| 1922788 | Ambrosia artemisiifolia pollen extract 100 UNT/ML / Ambrosia trifida pollen extract 100 UNT/ML Injectable Solution | SY | edcb6de3-85d9-4acb-97c2-27fc67218d79 | 4 |
| 1922790 | Ambrosia artemisiifolia pollen extract 20000 PNU/ML / Ambrosia trifida pollen extract 20000 PNU/ML Injectable Solution | SY | edcb6de3-85d9-4acb-97c2-27fc67218d79 | 4 |
| 1922790 | Ambrosia artemisiifolia pollen extract 20000 UNT/ML / Ambrosia trifida pollen extract 20000 UNT/ML Injectable Solution | SY | edcb6de3-85d9-4acb-97c2-27fc67218d79 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0268-8014-10 | 00268801410 | 10.5 mL in 1 VIAL (0268-8014-10) | 10.5 ml | 1975-01-15 | 0000-00-00 | No | No | Current |
| 0268-8014-30 | 00268801430 | 32 mL in 1 VIAL (0268-8014-30) | 32 ml | 1975-01-15 | 0000-00-00 | No | No | Current |