NDC 36987-2438

Smooth Brome

Smooth Brome

Smooth Brome 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 Bromus Inermis Pollen.

• Product ID: 36987-2438_5efa434d-c520-47eb-8524-f97ccebad6fc
• NDC: 36987-2438
• Product Type: Human Prescription Drug
• Proprietary Name: Smooth Brome
• Generic Name: Smooth Brome
• 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: BROMUS INERMIS POLLEN
• Active Ingredient Strength: 10000 [PNU]/mL
• Pharm Classes: Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 36987-2438-4

50 mL in 1 VIAL, MULTI-DOSE (36987-2438-4)

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

NDC SPL Data Element Entries

NDC 36987-2438-1 [36987243801]

Smooth Brome 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 36987-2438-4 [36987243804]

Smooth Brome 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 36987-2438-3 [36987243803]

Smooth Brome 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 36987-2438-2 [36987243802]

Smooth Brome 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
BROMUS INERMIS POLLEN	10000 [PNU]/mL

OpenFDA Data

• SPL SET ID: f826609e-90d3-43e4-a125-ce397fce965f
• Manufacturer:
  • Nelco Laboratories, Inc.
• UNII:
  • 50HCQ1NYV5
  • 766QT72BK6
  • V003SHB7VK
  • GOA51670YV
  • 74PD8J616H
  • 577VA5B4HP
  • 2XO08315X1
  • FAY1Y90VJ9
  • 6AU0ZD8T1O
  • A7IKY24TR7
  • 7U437HHU5C
  • F1KAH8374D
  • 257GC6QO0Q
  • ON2T85TA2O
  • I6KAZ8AO1O
• RxNorm Concept Unique ID - RxCUI:
  • 1044502
  • 897349
  • 889567
  • 1044523
  • 897357
  • 889668
  • 900010
  • 1014345
  • 899974
  • 1044252
  • 1000015
  • 900155
  • 898134
  • 897331
  • 1044494
  • 889532

Pharmacological Class

• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Non-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 "Smooth Brome" or generic name "Smooth Brome"

NDC	Brand Name	Generic Name
22840-1205	Smooth Brome	Bromus inermis
22840-1206	Smooth Brome	Bromus inermis
22840-1207	Smooth Brome	Bromus inermis
22840-1239	Smooth Brome	Bromus inermis
22840-1240	Smooth Brome	Bromus inermis
22840-1241	Smooth Brome	Bromus inermis
22840-5201	Smooth Brome	Bromus inermis
36987-2437	Smooth Brome	Smooth Brome
36987-2438	Smooth Brome	Smooth Brome
36987-2439	Smooth Brome	Smooth Brome
36987-2440	Smooth Brome	Smooth Brome
36987-2441	Smooth Brome	Smooth Brome
36987-2442	Smooth Brome	Smooth Brome
36987-2443	Smooth Brome	Smooth Brome
36987-2444	Smooth Brome	Smooth Brome