FDA.reportPublic FDA data

Coca-Glycerine Control

Product NDC
49288-0655
11-digit product format
492880655
Labeler code
49288
Product ID
49288-0655_fb54abb5-85cd-485f-9542-a2742a31bf72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Coca-Glycerine Control
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49288-0655-12019-10-21C16284748780-1956f9ecf-c62d-621f-e053-dbdaa90a74adAllergenic Extract
49288-0655-22019-10-21C16284748780-1956f9ecf-c62d-621f-e053-dbdaa90a74adAllergenic Extract
49288-0655-32019-10-21C16284748780-1956f9ecf-c62d-621f-e053-dbdaa90a74adAllergenic Extract
49288-0655-42019-10-21C16284748780-1956f9ecf-c62d-621f-e053-dbdaa90a74adAllergenic Extract
49288-0655-52019-10-21C16284748780-1956f9ecf-c62d-621f-e053-dbdaa90a74adAllergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49288-0655-1Coca-Glycerine Control2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION21
49288-0655-2Coca-Glycerine Control5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION51
49288-0655-3Coca-Glycerine Control10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION101
49288-0655-4Coca-Glycerine Control30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION301
49288-0655-5Coca-Glycerine Control50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXCOCA-GLYCERINE CONTROL INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
GLYCERINACTIVE MOIETYPDC6A3C0OXCOCA-GLYCERINE CONTROL INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCOCA-GLYCERINE CONTROL INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCOCA-GLYCERINE CONTROL INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOCA-GLYCERINE CONTROL INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49288-0655COCA-GLYCERINE CONTROL INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1Legacy NDC, 5 package rows20091209_9c75abf7-b941-4615-b059-bcc41c64d612.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49288-0655-1492880655012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
49288-0655-2492880655025 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
49288-0655-34928806550310 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
49288-0655-44928806550430 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
49288-0655-54928806550550 mL in 1 VIAL, MULTI-DOSE50 mlHistorical