NDC 36987-1251

Sardine

Sardine

Sardine 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 European Pilchard.

• Product ID: 36987-1251_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4
• NDC: 36987-1251
• Product Type: Human Prescription Drug
• Proprietary Name: Sardine
• Generic Name: Sardine
• 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: EUROPEAN PILCHARD
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 36987-1251-2

10 mL in 1 VIAL, MULTI-DOSE (36987-1251-2)

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

NDC SPL Data Element Entries

NDC 36987-1251-3 [36987125103]

Sardine 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 36987-1251-4 [36987125104]

Sardine 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 36987-1251-2 [36987125102]

Sardine 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 36987-1251-1 [36987125101]

Sardine 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
EUROPEAN PILCHARD	.05 g/mL

OpenFDA Data

• SPL SET ID: eeb27826-8811-4630-8ff6-e4926db34f38
• Manufacturer:
  • Nelco Laboratories, Inc.
• UNII:
  • BKZ683617P
  • 76780GX08D
  • 7062I37LB3
  • ZB2SV6JJY5
  • 0WLY635722
  • 01695YPV36
  • WF621S7K14
  • 5JKY494U4L
• RxNorm Concept Unique ID - RxCUI:
  • 905477
  • 899749
  • 901286
  • 901377
  • 966679
  • 900034
  • 905339
  • 905335
  • 905331
  • 901268
  • 905352
  • 899431
  • 901379
  • 899437
  • 899412
  • 966976
  • 905487
  • 905482
  • 899919
  • 905363
  • 901393
  • 905327

Pharmacological Class

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

NDC Crossover Matching brand name "Sardine" or generic name "Sardine"

NDC	Brand Name	Generic Name
36987-1250	Sardine	Sardine
36987-1251	Sardine	Sardine
36987-1252	Sardine	Sardine
36987-1253	Sardine	Sardine
49288-0477	Sardine	Sardine