FDA.reportPublic FDA data

Sterile Diluent for Allergenic Extract

Product NDC
49288-9933
11-digit product format
492889933
Labeler code
49288
Product ID
49288-9933_60ce9c8c-5855-42da-91ee-8bfe8edf51ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenol
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL; SUBCUTANEOUS
Labeler
Antigen Laboratories, Inc.
Application
BLA102223
Marketing category
BLA
Marketing start
1974-03-23
Marketing end
0000-00-00
Substance
PHENOL
Active strength
0 mL/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49288-9933-12019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9933-22019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9933-32019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9933-42019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9933-52019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9933-62019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9933-72019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9933-82019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9933-92019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49288-9933-1Sterile Diluent for Allergenic Extract2 mL in 1 VIALINJECTION, SOLUTION23
49288-9933-2Sterile Diluent for Allergenic Extract4 mL in 1 VIALINJECTION, SOLUTION43
49288-9933-3Sterile Diluent for Allergenic Extract4.5 mL in 1 VIALINJECTION, SOLUTION4.53
49288-9933-4Sterile Diluent for Allergenic Extract8 mL in 1 VIALINJECTION, SOLUTION83
49288-9933-5Sterile Diluent for Allergenic Extract9 mL in 1 VIALINJECTION, SOLUTION93
49288-9933-6Sterile Diluent for Allergenic Extract24 mL in 1 VIALINJECTION, SOLUTION243
49288-9933-7Sterile Diluent for Allergenic Extract30 mL in 1 VIALINJECTION, SOLUTION303
49288-9933-8Sterile Diluent for Allergenic Extract100 mL in 1 VIALINJECTION, SOLUTION1003
49288-9933-9Sterile Diluent for Allergenic Extract40 mL in 1 VIALINJECTION, SOLUTION403

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUMIN (HUMAN)ACTIVE INGREDIENTZIF514RVZRSTERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3
GLYCERINACTIVE INGREDIENTPDC6A3C0OXSTERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3
PHENOLACTIVE INGREDIENT339NCG44TVSTERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3
ALBUMIN (HUMAN)ACTIVE MOIETYZIF514RVZRSTERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3
GLYCERINACTIVE MOIETYPDC6A3C0OXSTERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3
PHENOLACTIVE MOIETY339NCG44TVSTERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3
POTASSIUM PHOSPHATEINACTIVE INGREDIENTB7862WZ632STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSTERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSTERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSTERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RSTERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49288-9933STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (HUMAN ALBUMIN AND PHENOL) INJECTION, SOLUTION STERILE DILUENT FOR ALLERGENIC EXTRACT (GLYCERINE) INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]3Legacy NDC, 9 package rows20091217_026d3185-aa37-42f8-95a0-7243e0947b7a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49288-9933-1492889933012 mL in 1 VIAL2 mlHistorical
49288-9933-2492889933024 mL in 1 VIAL4 mlHistorical
49288-9933-3492889933034.5 mL in 1 VIAL4.5 mlHistorical
49288-9933-4492889933048 mL in 1 VIAL8 mlHistorical
49288-9933-5492889933059 mL in 1 VIAL9 mlHistorical
49288-9933-64928899330624 mL in 1 VIAL24 mlHistorical
49288-9933-74928899330730 mL in 1 VIAL30 mlHistorical
49288-9933-849288993308100 mL in 1 VIAL100 mlHistorical
49288-9933-94928899330940 mL in 1 VIAL40 mlHistorical