standardized redtop grass

Generic: agrostis alba

Labeler: allermed laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name standardized redtop grass
Generic Name agrostis alba
Labeler allermed laboratories, inc.
Dosage Form INJECTION
Routes
CUTANEOUS INTRADERMAL SUBCUTANEOUS
Active Ingredients

agrostis gigantea pollen 100000 [BAU]/mL

Manufacturer
Allermed Laboratories, Inc.

Identifiers & Regulatory

Product NDC 49643-309
Product ID 49643-309_36ad5f03-e686-f1d0-e063-6394a90adfe8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA102218
Listing Expiration 2026-12-31
Marketing Start 1996-12-02

Pharmacologic Class

Established (EPC)
standardized pollen allergenic extract [epc] non-standardized pollen allergenic extract [epc]
Chemical Structure
pollen [cs] allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49643309
Hyphenated Format 49643-309

Supplemental Identifiers

RxCUI
851873 852157 853027 853047 853278 854054 854162 897496
UNII
2KIK19R45Y HU8V6E7HOA A0WFQ8P6N1 175F461W10 SCB8J7LS3T 4T81LB52R0 83N78IDA7P 65M88RW2EG
NUI
N0000185006 N0000175629 N0000184306 N0000185001 M0017130 M0000728 N0000185367

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name standardized redtop grass (source: ndc)
Generic Name agrostis alba (source: ndc)
Application Number BLA102218 (source: ndc)
Routes
CUTANEOUS INTRADERMAL SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100000 [BAU]/mL
source: ndc
Packaging
  • 5 mL in 1 VIAL, MULTI-DOSE (49643-309-05)
  • 10 mL in 1 VIAL, MULTI-DOSE (49643-309-10)
  • 30 mL in 1 VIAL, MULTI-DOSE (49643-309-30)
  • 50 mL in 1 VIAL, MULTI-DOSE (49643-309-50)
source: ndc

Packages (4)

49643-309-05 5 mL in 1 VIAL, MULTI-DOSE (49643-309-05) 49643-309-10 10 mL in 1 VIAL, MULTI-DOSE (49643-309-10) 49643-309-30 30 mL in 1 VIAL, MULTI-DOSE (49643-309-30) 49643-309-50 50 mL in 1 VIAL, MULTI-DOSE (49643-309-50)

Ingredients (1)

agrostis gigantea pollen (100000 [BAU]/mL)

Linked Drug Pages (1)

Standardized Redtop Grass, Standardized Sweet Vernal Grass, Standardized Bermuda Grass, Standardized Orchard Grass, Standardized Meadow Fescue Grass, Standardized Perennial Rye Grass, Standardized Timothy Grass, Standardized Kentucky Blue (June) Grass ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["CUTANEOUS", "INTRADERMAL", "SUBCUTANEOUS"], "spl_id": "36ad5f03-e686-f1d0-e063-6394a90adfe8", "openfda": {"nui": ["N0000185006", "N0000175629", "N0000184306", "N0000185001", "M0017130", "M0000728", "N0000185367"], "unii": ["2KIK19R45Y", "HU8V6E7HOA", "A0WFQ8P6N1", "175F461W10", "SCB8J7LS3T", "4T81LB52R0", "83N78IDA7P", "65M88RW2EG"], "rxcui": ["851873", "852157", "853027", "853047", "853278", "854054", "854162", "897496"], "spl_set_id": ["d33c3aed-f487-45ed-a465-365170c6450a"], "pharm_class_cs": ["Pollen [CS]", "Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Standardized Pollen Allergenic Extract [EPC]", "Non-Standardized Pollen Allergenic Extract [EPC]"], "manufacturer_name": ["Allermed Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, MULTI-DOSE (49643-309-05)", "package_ndc": "49643-309-05", "marketing_start_date": "19961202"}, {"sample": false, "description": "10 mL in 1 VIAL, MULTI-DOSE (49643-309-10)", "package_ndc": "49643-309-10", "marketing_start_date": "19961202"}, {"sample": false, "description": "30 mL in 1 VIAL, MULTI-DOSE (49643-309-30)", "package_ndc": "49643-309-30", "marketing_start_date": "19961202"}, {"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (49643-309-50)", "package_ndc": "49643-309-50", "marketing_start_date": "19961202"}], "brand_name": "Standardized Redtop Grass", "product_id": "49643-309_36ad5f03-e686-f1d0-e063-6394a90adfe8", "dosage_form": "INJECTION", "pharm_class": ["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]"], "product_ndc": "49643-309", "generic_name": "Agrostis alba", "labeler_name": "Allermed Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Standardized Redtop Grass", "active_ingredients": [{"name": "AGROSTIS GIGANTEA POLLEN", "strength": "100000 [BAU]/mL"}], "application_number": "BLA102218", "marketing_category": "BLA", "marketing_start_date": "19961202", "listing_expiration_date": "20261231"}