NDC 0268-8047

MIXED MOLDS

Alternaria Alternata, Aspergillus Flavus Var. Oryzae, Aspergillus Niger Var. Niger, Aspergillus Repens, Aspergillus Terreus, Cladosporium Sphaerospermum, Penicillium Chrysogenum Var. Chrysogenum, Penicillium Chrysogenum Var. Chrysogenum

MIXED MOLDS is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Alternaria Alternata; Cladosporium Sphaerospermum; Aspergillus Niger Var. Niger; Aspergillus Repens; Aspergillus Flavus Var. Oryzae; Aspergillus Terreus; Penicillium Chrysogenum Var. Chrysogenum.

Product ID	0268-8047_25c99df0-1f9c-45e1-950b-88e8cb11ed1d
NDC	0268-8047
Product Type	Non-standardized Allergenic
Proprietary Name	MIXED MOLDS
Generic Name	Alternaria Alternata, Aspergillus Flavus Var. Oryzae, Aspergillus Niger Var. Niger, Aspergillus Repens, Aspergillus Terreus, Cladosporium Sphaerospermum, Penicillium Chrysogenum Var. Chrysogenum, Penicillium Chrysogenum Var. Chrysogenum
Dosage Form	Injection, Solution
Route of Administration	SUBCUTANEOUS
Marketing Start Date	1965-01-01
Marketing Category	BLA / BLA
Application Number	BLA103753
Labeler Name	ALK-Abello, Inc.
Substance Name	ALTERNARIA ALTERNATA; CLADOSPORIUM SPHAEROSPERMUM; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
Active Ingredient Strength	20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL
Pharm Classes	Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]
NDC Exclude Flag	N
Listing Certified Through	2021-12-31

Packaging

NDC 0268-8047-10

10.5 mL in 1 VIAL (0268-8047-10)

Marketing Start Date	1965-01-01
NDC Exclude Flag	N
Sample Package?	N

NDC SPL Data Element Entries

NDC 0268-8047-50 [00268804750]

MIXED MOLDS INJECTION, SOLUTION

Marketing Category	BLA
Application Number	BLA103753
Product Type	NON-STANDARDIZED ALLERGENIC
Marketing Start Date	1965-01-01

NDC 0268-8047-10 [00268804710]

MIXED MOLDS INJECTION, SOLUTION

Marketing Category	BLA
Application Number	BLA103753
Product Type	NON-STANDARDIZED ALLERGENIC
Marketing Start Date	1965-01-01

Drug Details

Active Ingredients

Ingredient	Strength
ALTERNARIA ALTERNATA	20000 [PNU]/mL

Pharmacological Class

Non-Standardized Fungal Allergenic Extract [EPC]
Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Fungal Proteins [CS]
Allergens [CS]
Non-Standardized Fungal Allergenic Extract [EPC]
Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Fungal Proteins [CS]
Allergens [CS]
Non-Standardized Fungal Allergenic Extract [EPC]
Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Fungal Proteins [CS]
Allergens [CS]
Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Non-Standardized Fungal Allergenic Extract [EPC]
Fungal Proteins [CS]
Allergens [CS]
Non-Standardized Fungal Allergenic Extract [EPC]
Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Fungal Proteins [CS]
Allergens [CS]
Non-Standardized Fungal Allergenic Extract [EPC]
Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Fungal Proteins [CS]
Allergens [CS]

NDC Crossover Matching brand name "MIXED MOLDS" or generic name "Alternaria Alternata, Aspergillus Flavus Var. Oryzae, Aspergillus Niger Var. Niger, Aspergillus Repens, Aspergillus Terreus, Cladosporium Sphaerospermum, Penicillium Chrysogenum Var. Chrysogenum, Penicillium Chrysogenum Var. Chrysogenum"

NDC	Brand Name	Generic Name
0268-8045	MIXED MOLDS	ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM and PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
0268-8046	MIXED MOLDS	ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
0268-8047	MIXED MOLDS	ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
0268-8048	MIXED MOLDS	ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
0268-8049	MIXED MOLDS	ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM, ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS, PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM
0268-8050	MIXED MOLDS	ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM, ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS, PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM