FDA.reportPublic FDA data

Para Grass Pollen

Product NDC
36987-2354
11-digit product format
369872354
Labeler code
36987
Product ID
36987-2354_e0e5cad7-f73f-49ca-b0fe-e59630c501fa
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
0 g/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

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
36987-2354-12019-10-21C16284748780-1956f9ecf-d8f9-621f-e053-dbdaa90a74adAllergenic Extract
36987-2354-22019-10-21C16284748780-1956f9ecf-d8f9-621f-e053-dbdaa90a74adAllergenic Extract
36987-2354-32019-10-21C16284748780-1956f9ecf-d8f9-621f-e053-dbdaa90a74adAllergenic Extract
36987-2354-42019-10-21C16284748780-1956f9ecf-d8f9-621f-e053-dbdaa90a74adAllergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36987-2354-1Para Grass Pollen5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52
36987-2354-2Para Grass Pollen10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102
36987-2354-3Para Grass Pollen30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302
36987-2354-4Para 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
36987-2354PARA GRASS POLLEN INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2Legacy NDC, 4 package rows20100107_34c8c68c-9a78-42ea-89f8-cac82981881e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044402para grass pollen extract 100 MG/ML Injectable SolutionPSN34c8c68c-9a78-42ea-89f8-cac82981881e2
1044402para grass pollen extract 100 MG/ML Injectable SolutionSCD34c8c68c-9a78-42ea-89f8-cac82981881e2
1044402Urochloa mutica pollen extract 0.1 GM/ML Injectable SolutionSY34c8c68c-9a78-42ea-89f8-cac82981881e2
1044402Urochloa mutica pollen extract 100 MG/ML Injectable SolutionSY34c8c68c-9a78-42ea-89f8-cac82981881e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
36987-2354-1369872354015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
36987-2354-23698723540210 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
36987-2354-33698723540330 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
36987-2354-43698723540450 mL in 1 VIAL, MULTI-DOSE50 mlHistorical