Nigrospora sphaerica

Product NDC
36987-2019
11-digit product format
369872019
Labeler code
36987
Product ID
36987-2019_df67ce4b-b36a-4b3b-a1dc-0f6f00661092
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nigrospora sphaerica
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
KHUSKIA ORYZAE
Active strength
10000 [PNU]/mL
Pharmacologic classes
Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36987-2019-1Nigrospora sphaerica5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION51
36987-2019-2Nigrospora sphaerica10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION101
36987-2019-3Nigrospora sphaerica30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION301
36987-2019-4Nigrospora sphaerica50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION501

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36987-2019NIGROSPORA SPHAERICA INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1Legacy NDC, 4 package rows20100106_3916eb5c-7111-45d0-9bfd-40525616fd83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892475Khuskia oryzae allergenic extract 10000 UNT/ML Injectable SolutionPSN3916eb5c-7111-45d0-9bfd-40525616fd831
892475Khuskia oryzae allergenic extract 10000 UNT/ML Injectable SolutionSCD3916eb5c-7111-45d0-9bfd-40525616fd831
892475Nigrospora sphaerica allergenic extract 10,000 UNT/ML Injectable SolutionSY3916eb5c-7111-45d0-9bfd-40525616fd831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
36987-2019-1369872019015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
36987-2019-23698720190210 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
36987-2019-33698720190330 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
36987-2019-43698720190450 mL in 1 VIAL, MULTI-DOSE50 mlHistorical