FDA.reportPublic FDA data

Sterile Diluent for Allergenic Extract

Product NDC
49288-9935
11-digit product format
492889935
Labeler code
49288
Product ID
49288-9935_60ce9c8c-5855-42da-91ee-8bfe8edf51ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycerine
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
GLYCERIN
Active strength
1 mL/mL
Pharmacologic classes
Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Glycerol [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49288-9935IInactivated by FDA2026-07-31
excluded packagepackage49288-993549288-9935-1IInactivated by FDA2026-07-31
excluded packagepackage49288-993549288-9935-2IInactivated by FDA2026-07-31
excluded packagepackage49288-993549288-9935-3IInactivated by FDA2026-07-31
excluded packagepackage49288-993549288-9935-4IInactivated by FDA2026-07-31
excluded packagepackage49288-993549288-9935-5IInactivated by FDA2026-07-31
excluded packagepackage49288-993549288-9935-6IInactivated by FDA2026-07-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49288-9935-12019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9935-22019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9935-32019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9935-42019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9935-52019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract
49288-9935-62019-10-21C16284748780-1956f9ecf-dbb1-621f-e053-dbdaa90a74adAllergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49288-9935-1Sterile Diluent for Allergenic Extract4 mL in 1 VIALINJECTION, SOLUTION43
49288-9935-2Sterile Diluent for Allergenic Extract4.5 mL in 1 VIALINJECTION, SOLUTION4.53
49288-9935-3Sterile Diluent for Allergenic Extract8 mL in 1 VIALINJECTION, SOLUTION83
49288-9935-4Sterile Diluent for Allergenic Extract9 mL in 1 VIALINJECTION, SOLUTION93
49288-9935-5Sterile Diluent for Allergenic Extract24 mL in 1 VIALINJECTION, SOLUTION243
49288-9935-6Sterile Diluent for Allergenic Extract100 mL in 1 VIALINJECTION, SOLUTION1003

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
49288-9935STERILE 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, 6 package rows20091217_026d3185-aa37-42f8-95a0-7243e0947b7a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49288-9935-1492889935014 mL in 1 VIAL4 mlHistorical
49288-9935-2492889935024.5 mL in 1 VIAL4.5 mlHistorical
49288-9935-3492889935038 mL in 1 VIAL8 mlHistorical
49288-9935-4492889935049 mL in 1 VIAL9 mlHistorical
49288-9935-54928899350524 mL in 1 VIAL24 mlHistorical
49288-9935-649288993506100 mL in 1 VIAL100 mlHistorical