NDC 36987-3255

Rough Marsh Elder

Rough Marsh Elder

Rough Marsh Elder 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 Iva Annua Var. Annua Pollen.

• Product ID: 36987-3255_d152b7aa-b962-4303-9744-c8947edc1d6d
• NDC: 36987-3255
• Product Type: Human Prescription Drug
• Proprietary Name: Rough Marsh Elder
• Generic Name: Rough Marsh Elder
• 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: IVA ANNUA VAR. ANNUA POLLEN
• Active Ingredient Strength: 20000 [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]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 36987-3255-4

50 mL in 1 VIAL, MULTI-DOSE (36987-3255-4)

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

NDC SPL Data Element Entries

NDC 36987-3255-1 [36987325501]

Rough Marsh Elder 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 36987-3255-2 [36987325502]

Rough Marsh Elder 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 36987-3255-3 [36987325503]

Rough Marsh Elder 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 36987-3255-4 [36987325504]

Rough Marsh Elder 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
IVA ANNUA VAR. ANNUA POLLEN	20000 [PNU]/mL

OpenFDA Data

• SPL SET ID: efc51970-c1a4-45e7-864b-4f0587896459
• Manufacturer:
  • Nelco Laboratories, Inc.
• UNII:
  • U2AI3H2J5Y
  • 92N6W6KO2G
  • 2A64U81OQ3
  • 68R9X9Y96X
  • 098LKX5NCN
  • 380W4HYR6N
  • YB1308W43O
  • 644CZ16IR5
  • BBO1IJ3ZIW
  • DO87T1U2CI
  • YI19RB8YFD
  • JQ87AA60GU
  • 6532U64A3X
  • 81GS97HVFO
  • RX18M46K8L
  • 86LWA5503I
  • 2MH135KC6G
  • 5W6JAI84OI
  • V825XJG64G
  • 1GH3WV23KH
  • 2QOF601J1M
  • WIB701MW2H
  • WQ3S5294XY
  • N52MIQ81ZW
  • O4AB4546TP
  • DNB59M1NVU
  • 26U0BU8G83
  • B67NF86HF0
  • 57KIJ4772H
  • ANT994T71D
  • KU1V1898XX
  • 13KFG30UBR
  • 73B14PX5FW
• RxNorm Concept Unique ID - RxCUI:
  • 896125
  • 897966
  • 897313
  • 896288
  • 1006365
  • 895677
  • 1006486
  • 895612
  • 895912
  • 896208
  • 897374
  • 896088
  • 896263
  • 1013972
  • 1013970
  • 897400
  • 897995
  • 897975
  • 897957
  • 896171
  • 901475
  • 896298
  • 901493
  • 1006357
  • 896156
  • 897325
  • 896078
  • 895725
  • 1006492
  • 897341
  • 896255
  • 896196
  • 897512
  • 897382
  • 898337
  • 897949
  • 896279

Pharmacological Class

• 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 "Rough Marsh Elder" or generic name "Rough Marsh Elder"

NDC	Brand Name	Generic Name
36987-3253	Rough Marsh Elder	Rough Marsh Elder
36987-3254	Rough Marsh Elder	Rough Marsh Elder
36987-3255	Rough Marsh Elder	Rough Marsh Elder
36987-3256	Rough Marsh Elder	Rough Marsh Elder
36987-3257	Rough Marsh Elder	Rough Marsh Elder
36987-3258	Rough Marsh Elder	Rough Marsh Elder
36987-3259	Rough Marsh Elder	Rough Marsh Elder
36987-3260	Rough Marsh Elder	Rough Marsh Elder
49288-0270	Rough Marsh Elder	Rough Marsh Elder
49288-0271	Rough Marsh Elder	Rough Marsh Elder