FDA.reportPublic FDA data

Para Grass Pollen

Product NDC
36987-2349
11-digit product format
369872349
Labeler code
36987
Product ID
36987-2349_4e286c80-4d2a-433b-9ea5-2e7678db4c2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Para Grass Pollen
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL; SUBCUTANEOUS
Labeler
Nelco Laboratories, Inc.
Application
BLA102192
Marketing category
BLA
Marketing start
1972-08-29
Marketing end
0000-00-00
Substance
UROCHLOA MUTICA POLLEN
Active strength
20000 [PNU]/mL
Pharmacologic classes
Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36987-2349-12019-10-21C16284748780-1956f9ecf-d77c-621f-e053-dbdaa90a74adAllergenic Extract
36987-2349-22019-10-21C16284748780-1956f9ecf-d77c-621f-e053-dbdaa90a74adAllergenic Extract
36987-2349-32019-10-21C16284748780-1956f9ecf-d77c-621f-e053-dbdaa90a74adAllergenic Extract
36987-2349-42019-10-21C16284748780-1956f9ecf-d77c-621f-e053-dbdaa90a74adAllergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36987-2349-1Para Grass Pollen5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52
36987-2349-2Para Grass Pollen10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102
36987-2349-3Para Grass Pollen30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302
36987-2349-4Para Grass Pollen50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UROCHLOA MUTICA POLLENACTIVE INGREDIENT3ZO9YGZ8ZJPARA GRASS POLLEN INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2
UROCHLOA MUTICA POLLENACTIVE MOIETY3ZO9YGZ8ZJPARA GRASS POLLEN INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2
PHENOLINACTIVE INGREDIENT339NCG44TVPARA GRASS POLLEN INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOPARA GRASS POLLEN INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPARA GRASS POLLEN INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPARA GRASS POLLEN INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36987-2349PARA GRASS POLLEN INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2Legacy NDC, 4 package rows20100107_c3a71011-228e-4ef0-bf4e-be771a943d02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
894794para grass pollen extract 20000 UNT/ML Injectable SolutionPSNc3a71011-228e-4ef0-bf4e-be771a943d022
894794para grass pollen extract 20000 UNT/ML Injectable SolutionSCDc3a71011-228e-4ef0-bf4e-be771a943d022
894794Urochloa mutica pollen extract 20,000 UNT/ML Injectable SolutionSYc3a71011-228e-4ef0-bf4e-be771a943d022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
36987-2349-1369872349015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
36987-2349-23698723490210 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
36987-2349-33698723490330 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
36987-2349-43698723490450 mL in 1 VIAL, MULTI-DOSE50 mlHistorical