NDC 49288-9934

Sterile Diluent for Allergenic Extract

Human Albumin And Phenol

Sterile Diluent for Allergenic Extract is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Albumin (human); Phenol.

• Product ID: 49288-9934_60ce9c8c-5855-42da-91ee-8bfe8edf51ab
• NDC: 49288-9934
• Product Type: Human Prescription Drug
• Proprietary Name: Sterile Diluent for Allergenic Extract
• Generic Name: Human Albumin And Phenol
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1974-03-23
• Marketing Category: BLA / BLA
• Application Number: BLA102223
• Labeler Name: Antigen Laboratories, Inc.
• Substance Name: ALBUMIN (HUMAN); PHENOL
• Active Ingredient Strength: 0 mL/mL; mL/mL
• Pharm Classes: Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-9934-4

9 mL in 1 VIAL (49288-9934-4)

• Marketing Start Date: 1974-03-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49288-9934-5 [49288993405]

Sterile Diluent for Allergenic Extract INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-21

NDC 49288-9934-1 [49288993401]

Sterile Diluent for Allergenic Extract INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-21

NDC 49288-9934-3 [49288993403]

Sterile Diluent for Allergenic Extract INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-21

NDC 49288-9934-2 [49288993402]

Sterile Diluent for Allergenic Extract INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-21

NDC 49288-9934-4 [49288993404]

Sterile Diluent for Allergenic Extract INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
ALBUMIN (HUMAN)	.0003 mL/mL

OpenFDA Data

• SPL SET ID: 026d3185-aa37-42f8-95a0-7243e0947b7a
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • 339NCG44TV
  • PDC6A3C0OX
  • ZIF514RVZR
• Pharm Class PE:
  • Increased Oncotic Pressure [PE]
  • Increased Intravascular Volume [PE]
• PHarm Class EPC:
  • Human Serum Albumin [EPC]
• UPC Code:
  • 0349288993216
  • 0349288993414
  • 0349288993513
  • 0349288993315
• NUI Code:
  • N0000010288
  • N0000009361
  • N0000169504
  • N0000009457
  • N0000184174

Pharmacological Class

• Human Serum Albumin [EPC]
• Increased Intravascular Volume [PE]
• Increased Oncotic Pressure [PE]
• Osmotic Activity [MoA]
• Serum Albumin [Chemical/Ingredient]

NDC Crossover Matching brand name "Sterile Diluent for Allergenic Extract" or generic name "Human Albumin And Phenol"

NDC	Brand Name	Generic Name
49288-9932	Sterile Diluent for Allergenic Extract	Glycerine and Phenol
49288-9933	Sterile Diluent for Allergenic Extract	Phenol
49288-9934	Sterile Diluent for Allergenic Extract	Human Albumin and Phenol
49288-9935	Sterile Diluent for Allergenic Extract	Glycerine
49288-9936	Sterile Diluent for Allergenic Extract	Glycerine and Phenol