NDC 36987-2534

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: 36987-2534_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6
• NDC: 36987-2534
• 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: 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]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 36987-2534-1

5 mL in 1 VIAL, MULTI-DOSE (36987-2534-1)

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

NDC SPL Data Element Entries

NDC 36987-2534-1 [36987253401]

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 36987-2534-3 [36987253403]

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 36987-2534-2 [36987253402]

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 36987-2534-4 [36987253404]

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	10000 [PNU]/mL

OpenFDA Data

• SPL SET ID: 3baaac54-68e4-47a3-b0c7-fb9b5b8d6271
• 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:
  • 1043675
  • 900876
  • 897980
  • 900927
  • 1044324
  • 895360
  • 895681
  • 1013925
  • 900955
  • 1013900
  • 1044385
  • 900966
  • 899982
  • 1044517
  • 900981
  • 900054
  • 1014716
  • 884183
  • 900718
  • 1044343
  • 883497
  • 900738
  • 1013885
  • 1044267
  • 1014320
  • 1043793
  • 895447
  • 1006480
  • 1014701
  • 889632
  • 900971
  • 900118
  • 1014446
  • 899600
  • 1014349
  • 899696
  • 898021
  • 1013957
  • 899966
  • 1013878
  • 307987
  • 1115276
  • 889560
  • 1043787
  • 897859
  • 1014682
  • 901503
  • 1044337
  • 895691
  • 1006474
  • 901023
  • 895376
  • 898130
  • 1044392
  • 1014309
  • 307966
  • 1044228
  • 901029
  • 1044398
  • 898415
  • 1044209
  • 899568
  • 900845
  • 1014266
  • 899583
  • 1044222
  • 895600
  • 899618
  • 897345
  • 1232582
  • 889645
  • 897557
  • 895706
  • 1232567
  • 898398
  • 897364
  • 1013947
  • 884079
  • 1299998
  • 897414
  • 895472
  • 898400
  • 1014444
  • 897412

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