FDA.reportPublic FDA data

California Mugwort

Product NDC
36987-3278
11-digit product format
369873278
Labeler code
36987
Product ID
36987-3278_afd9ee5b-b6ea-4bde-af79-31cf9b90dabb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
California Mugwort
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
ARTEMISIA DOUGLASIANA POLLEN
Active strength
10000 [PNU]/mL
Pharmacologic classes
Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Cell-mediated Immunity [PE]
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
36987-3278-12019-10-21C16284748780-1956f9ecf-bedd-621f-e053-dbdaa90a74adAllergenic Extract
36987-3278-22019-10-21C16284748780-1956f9ecf-bedd-621f-e053-dbdaa90a74adAllergenic Extract
36987-3278-32019-10-21C16284748780-1956f9ecf-bedd-621f-e053-dbdaa90a74adAllergenic Extract
36987-3278-42019-10-21C16284748780-1956f9ecf-bedd-621f-e053-dbdaa90a74adAllergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36987-3278-1California Mugwort5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52
36987-3278-2California Mugwort10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102
36987-3278-3California Mugwort30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302
36987-3278-4California Mugwort50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARTEMISIA DOUGLASIANA POLLENACTIVE INGREDIENTK1301R7883CALIFORNIA MUGWORT INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2
ARTEMISIA DOUGLASIANA POLLENACTIVE MOIETYK1301R7883CALIFORNIA MUGWORT INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALIFORNIA MUGWORT INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2
PHENOLINACTIVE INGREDIENT339NCG44TVCALIFORNIA MUGWORT INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCALIFORNIA MUGWORT INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCALIFORNIA MUGWORT INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCALIFORNIA MUGWORT INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36987-3278CALIFORNIA MUGWORT INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2Legacy NDC, 4 package rows20100107_e1a0f4d9-3bd9-4cf9-a09e-359015738c38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
894818California mugwort pollen extract 10000 UNT/mL Injectable SolutionPSNe1a0f4d9-3bd9-4cf9-a09e-359015738c382
894818California mugwort pollen extract 10000 UNT/ML Injectable SolutionSCDe1a0f4d9-3bd9-4cf9-a09e-359015738c382
894818Artemisia douglasiana pollen extract 10,000 UNT/ML Injectable SolutionSYe1a0f4d9-3bd9-4cf9-a09e-359015738c382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
36987-3278-1369873278015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
36987-3278-23698732780210 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
36987-3278-33698732780330 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
36987-3278-43698732780450 mL in 1 VIAL, MULTI-DOSE50 mlHistorical