NDC 49643-386

Standardized Timothy Grass

Phleum Pratense

Standardized Timothy Grass is a Cutaneous; Intradermal; Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Allermed Laboratories, Inc.. The primary component is Phleum Pratense Pollen.

• Product ID: 49643-386_92edfda3-37dd-daa1-e053-2a95a90a5c1f
• NDC: 49643-386
• Product Type: Human Prescription Drug
• Proprietary Name: Standardized Timothy Grass
• Generic Name: Phleum Pratense
• Dosage Form: Injection
• Route of Administration: CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1996-12-02
• Marketing Category: BLA / BLA
• Application Number: BLA102221
• Labeler Name: Allermed Laboratories, Inc.
• Substance Name: PHLEUM PRATENSE POLLEN
• Active Ingredient Strength: 100000 [BAU]/mL
• Pharm Classes: Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 49643-386-05

5 mL in 1 VIAL, MULTI-DOSE (49643-386-05)

• Marketing Start Date: 1996-12-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49643-386-50 [49643038650]

Standardized Timothy Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102221
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-386-05 [49643038605]

Standardized Timothy Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102221
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-386-30 [49643038630]

Standardized Timothy Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102221
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-386-10 [49643038610]

Standardized Timothy Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102221
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

Drug Details

Active Ingredients

Ingredient	Strength
PHLEUM PRATENSE POLLEN	100000 [BAU]/mL

Pharmacological Class

• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]

NDC Crossover Matching brand name "Standardized Timothy Grass" or generic name "Phleum Pratense"

NDC	Brand Name	Generic Name
49643-386	Standardized Timothy Grass	Phleum pratense
22840-0213	Standardized Timothy Pollen	Phleum pratense
22840-0214	Standardized Timothy Pollen	Phleum pratense