NDC 49288-0477

Sardine

Sardine

Sardine is a Intradermal; Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is European Pilchard.

• Product ID: 49288-0477_28463a0e-70af-4169-b592-df65f4f13a5f
• NDC: 49288-0477
• Product Type: Non-standardized Allergenic
• Proprietary Name: Sardine
• Generic Name: Sardine
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1974-03-23
• Marketing Category: BLA / BLA
• Application Number: BLA102223
• Labeler Name: Antigen 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 49288-0477-5

50 mL in 1 VIAL, MULTI-DOSE (49288-0477-5)

• Marketing Start Date: 1974-03-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49288-0477-3 [49288047703]

Sardine INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-29

NDC 49288-0477-4 [49288047704]

Sardine INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-29

NDC 49288-0477-2 [49288047702]

Sardine INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-29

NDC 49288-0477-1 [49288047701]

Sardine INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-29

NDC 49288-0477-5 [49288047705]

Sardine INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
EUROPEAN PILCHARD	.05 g/mL

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