FDA.reportPublic FDA data

California Mugwort

Product NDC
36987-3280
11-digit product format
369873280
Labeler code
36987
Product ID
36987-3280_2ae15a58-71ac-4434-bb4b-cc2fb15e22c0
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
20000 [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

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
36987-3280-12019-10-21C16284748780-1956f9ecf-c81c-621f-e053-dbdaa90a74adAllergenic Extract
36987-3280-22019-10-21C16284748780-1956f9ecf-c81c-621f-e053-dbdaa90a74adAllergenic Extract
36987-3280-32019-10-21C16284748780-1956f9ecf-c81c-621f-e053-dbdaa90a74adAllergenic Extract
36987-3280-42019-10-21C16284748780-1956f9ecf-c81c-621f-e053-dbdaa90a74adAllergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36987-3280-1California Mugwort5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52
36987-3280-2California Mugwort10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102
36987-3280-3California Mugwort30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302
36987-3280-4California 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
36987-3280CALIFORNIA MUGWORT INJECTION, SOLUTION [NELCO LABORATORIES, INC.]2Legacy NDC, 4 package rows20100107_9dcb362f-1126-4bb9-abe2-114935c58efb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
894978California mugwort pollen extract 20000 UNT/mL Injectable SolutionPSN9dcb362f-1126-4bb9-abe2-114935c58efb2
894978California mugwort pollen extract 20000 UNT/ML Injectable SolutionSCD9dcb362f-1126-4bb9-abe2-114935c58efb2
894978Artemisia douglasiana pollen extract 20,000 UNT/ML Injectable SolutionSY9dcb362f-1126-4bb9-abe2-114935c58efb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
36987-3280-1369873280015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
36987-3280-23698732800210 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
36987-3280-33698732800330 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
36987-3280-43698732800450 mL in 1 VIAL, MULTI-DOSE50 mlHistorical