NDC 36987-2535

Birch

Birch

Birch 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 Betula Nigra Pollen.

• Product ID: 36987-2535_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5
• NDC: 36987-2535
• Product Type: Human Prescription Drug
• Proprietary Name: Birch
• Generic Name: Birch
• 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: BETULA NIGRA 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 36987-2535-2

10 mL in 1 VIAL, MULTI-DOSE (36987-2535-2)

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

NDC SPL Data Element Entries

NDC 36987-2535-1 [36987253501]

Birch 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 36987-2535-4 [36987253504]

Birch 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 36987-2535-3 [36987253503]

Birch 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 36987-2535-2 [36987253502]

Birch 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
BETULA NIGRA POLLEN	20000 [PNU]/mL

OpenFDA Data

• SPL SET ID: de47ad70-b2be-4103-a402-35463ebffc87
• Manufacturer:
  • Nelco Laboratories, Inc.
• UNII:
  • 928OC2TJDA
  • E03U1K03LK
  • 3MDX759C0W
  • 700NK45C76
  • Z0F2YK1B7H
  • 2147EPR64I
  • 59WAV8G5X5
  • 3I9T68187H
  • 8003NOJ82F
  • E4CG5Q55M1
  • 5Q246DS5BS
  • E3A7U1HWIO
  • G2A764T54B
  • 43R41XZ627
  • QJB9OQO689
  • G82398SD3I
  • E2B4Q4BXJG
  • TX1ER5UV3T
  • 15L060HV8H
  • P6K070AR8V
  • 0U790UB32K
  • 7JWJ3HXZ9U
  • LC8MEV9S89
  • 89BAT511BD
  • 6M2JIH93ZN
  • O12H03B41R
  • 232DMH0XVF
  • 23H70FYJ5U
  • 5928LJ1441
  • 95447163DG
  • HGH5K3653K
  • G684LX721Q
  • 68P4F4M6VD
  • ZGS382Y3AV
  • 426RHB4302
  • VOT5MA71M7
  • 34X886W1H4
  • 9LYI4RTZ52
  • 0G82TT8ZFY
  • PYO4JR720Y
  • 57BTU4547U
  • 84ZOM591BB
  • NX974IRT8E
  • 0MGE63QPFJ
  • VU8C8SB23P
  • ER172J09FM
  • PY0JA16R2G
  • Y3FRX92Z0E
  • Z4Y9ZSV4KK
  • 4O1FFR8ARN
  • 93963RFO1P
  • JQ5HI5004M
  • S8A4X05W7J
  • 1FH355G8HF
  • 9HC15X34LX
  • 96LRW14765
  • 6U600U1326
  • 476DVV63WP
  • 6EIJ3D04MR
  • 030R993R8E
  • OZJ4OE173N
  • 8KDG09A4GO
  • PM6E3FG1QK
  • 544F8MEY0Y
  • BS3OW0RZ4K
  • SVW19ET93C
  • LJT6I6Z8FD
  • 605T96G8Y5
  • ARW43087I1
  • 43IR7KR479
  • 7X8HL8GRTM
  • 1BV28146ZR
  • 808UWJ59FI
  • 51I6N3XIML
  • M0G28FH9K1
  • BWC8DYU8OS
  • 54UN9R2798
  • 02RVY6X9EC
  • V38QUQ7861
  • 042SUA2DS9
  • 7XW7TB10X9
  • P6818UI2E4
  • 294L626TT0
• RxNorm Concept Unique ID - RxCUI:
  • 1014335
  • 1044512
  • 889558
  • 1014689
  • 1043789
  • 900896
  • 1014684
  • 895362
  • 1044339
  • 1013902
  • 1013927
  • 895685
  • 1014357
  • 900940
  • 1044387
  • 898422
  • 899570
  • 883499
  • 1014718
  • 900074
  • 1013887
  • 1014311
  • 1044400
  • 1013880
  • 1013873
  • 1013869
  • 900030
  • 889630
  • 899602
  • 895449
  • 1044490
  • 899686
  • 1013951
  • 1044355
  • 1044347
  • 899968
  • 1013959
  • 1044213
  • 1044486
  • 1043795
  • 899960
  • 900957
  • 1044357
  • 895378
  • 1014699
  • 1044316
  • 1300000
  • 1014324
  • 1014771
  • 1014222
  • 1006476
  • 1013910
  • 895694
  • 1044300
  • 1043685
  • 900040
  • 899561
  • 899634
  • 899588
  • 1014268
  • 900088
  • 1232595
  • 1044224
  • 899779
  • 900720
  • 1044320
  • 895602
  • 1232570
  • 895708
  • 1044230
  • 1115278
  • 889642
  • 900740
  • 895474
  • 1044519
  • 1013942
  • 899678
  • 1044327
  • 1013968
  • 900056
  • 900120
  • 899698
  • 901031
  • 899984

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 "Birch" or generic name "Birch"

NDC	Brand Name	Generic Name
36987-2533	Birch	Birch
36987-2534	Birch	Birch
36987-2535	Birch	Birch
36987-2536	Birch	Birch
36987-2537	Birch	Birch
36987-2538	Birch	Birch
36987-2539	Birch	Birch
36987-2540	Birch	Birch