NDC 36987-1644

Karaya Gum

Karaya Gum

Karaya Gum is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Karaya Gum.

• Product ID: 36987-1644_d776fd84-c01f-4483-9146-5d715e675716
• NDC: 36987-1644
• Product Type: Human Prescription Drug
• Proprietary Name: Karaya Gum
• Generic Name: Karaya Gum
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1972-08-29
• Marketing Category: BLA / BLA
• Application Number: BLA102192
• Labeler Name: Nelco Laboratories, Inc.
• Substance Name: KARAYA GUM
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [CS],Food Additives [CS],Allergens [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 36987-1644-2

10 mL in 1 VIAL, MULTI-DOSE (36987-1644-2)

• Marketing Start Date: 1972-08-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36987-1644-3 [36987164403]

Karaya Gum INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

NDC 36987-1644-2 [36987164402]

Karaya Gum INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

NDC 36987-1644-1 [36987164401]

Karaya Gum INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

NDC 36987-1644-4 [36987164404]

Karaya Gum INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
KARAYA GUM	.01 g/mL

OpenFDA Data

• SPL SET ID: 6673dd1e-f02f-4fcc-9037-003e666041d9
• Manufacturer:
  • Nelco Laboratories, Inc.
• UNII:
  • 5X9Y89ENI9
  • LN7IM9RDEA
  • 5C5403N26O
  • 73W9IQY50Q
  • 2944357O2O
• RxNorm Concept Unique ID - RxCUI:
  • 904557
  • 905249
  • 905308
  • 1232636
  • 905245
  • 1232634
  • 904573
  • 905304

Pharmacological Class

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

NDC Crossover Matching brand name "Karaya Gum" or generic name "Karaya Gum"

NDC	Brand Name	Generic Name
0268-6143	KARAYA GUM	Karaya Gum Bassora
22840-1525	Karaya Gum	Sterculia urens
22840-1557	Karaya Gum	Sterculia urens
22840-5512	Karaya Gum	Sterculia urens
36987-1642	Karaya Gum	Karaya Gum
36987-1644	Karaya Gum	Karaya Gum
49643-018	Karaya Gum	Karaya Gum