FDA.reportPublic FDA data

Pyrethrum

Product NDC
49288-0403
11-digit product format
492880403
Labeler code
49288
Product ID
49288-0403_3af4be6b-c022-4834-9006-f6cc8d8041da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyrethrum
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL; SUBCUTANEOUS
Labeler
Antigen Laboratories, Inc.
Application
BLA102223
Marketing category
BLA
Marketing start
1974-03-23
Marketing end
0000-00-00
Substance
PYRETHRUM CINERARIIFOLIUM
Active strength
0 g/mL
Pharmacologic classes
Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [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
49288-0403-12019-10-21C16284748780-1956f9ecf-c8cd-621f-e053-dbdaa90a74adAllergenic Extract
49288-0403-22019-10-21C16284748780-1956f9ecf-c8cd-621f-e053-dbdaa90a74adAllergenic Extract
49288-0403-32019-10-21C16284748780-1956f9ecf-c8cd-621f-e053-dbdaa90a74adAllergenic Extract
49288-0403-42019-10-21C16284748780-1956f9ecf-c8cd-621f-e053-dbdaa90a74adAllergenic Extract
49288-0403-52019-10-21C16284748780-1956f9ecf-c8cd-621f-e053-dbdaa90a74adAllergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49288-0403-1Pyrethrum2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION22
49288-0403-2Pyrethrum5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52
49288-0403-3Pyrethrum10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102
49288-0403-4Pyrethrum30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302
49288-0403-5Pyrethrum50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEIBA PENTANDRA FIBERACTIVE INGREDIENT758Z9H9WV9COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
CORCORUS CAPSULARIS FIBERACTIVE INGREDIENTTVA75O7S63COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
COTTON FIBERACTIVE INGREDIENT70LDW53ROOCOTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
IRIS GERMANICA VAR. FLORENTINA ROOTACTIVE INGREDIENTM30XO5X4XDCOTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
PYRETHRUM CINERARIIFOLIUMACTIVE INGREDIENTCGF76TP7X6COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
TOBACCO LEAFACTIVE INGREDIENT6YR2608RSUCOTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
CEIBA PENTANDRA FIBERACTIVE MOIETY758Z9H9WV9COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
CORCORUS CAPSULARIS FIBERACTIVE MOIETYTVA75O7S63COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
COTTON FIBERACTIVE MOIETY70LDW53ROOCOTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
IRIS GERMANICA VAR. FLORENTINA ROOTACTIVE MOIETYM30XO5X4XDCOTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
PYRETHRUM CINERARIIFOLIUMACTIVE MOIETYCGF76TP7X6COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
TOBACCO LEAFACTIVE MOIETY6YR2608RSUCOTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCOTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCOTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2
WATERINACTIVE INGREDIENT059QF0KO0RCOTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49288-0403COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]2Legacy NDC, 5 package rows20091119_d71013ab-718c-4cb0-ae1a-31fdd6db8851.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966928cotton fiber allergenic extract 50 MG/ML Injectable SolutionPSNd71013ab-718c-4cb0-ae1a-31fdd6db88512
1014199jute fiber allergenic extract 50 MG/mL Injectable SolutionPSNd71013ab-718c-4cb0-ae1a-31fdd6db88512
904965kapok tree fiber allergenic extract 50 MG/mL Injectable SolutionPSNd71013ab-718c-4cb0-ae1a-31fdd6db88512
852547orris root allergenic extract 100 MG/ML Injectable SolutionPSNd71013ab-718c-4cb0-ae1a-31fdd6db88512
1098356orris root allergenic extract 50 MG/ML Injectable SolutionPSNd71013ab-718c-4cb0-ae1a-31fdd6db88512
967973Pyrethrum cinerariifolium allergenic extract 50 MG/ML Injectable SolutionPSNd71013ab-718c-4cb0-ae1a-31fdd6db88512
852065tobacco leaf allergenic extract 100 MG/mL Injectable SolutionPSNd71013ab-718c-4cb0-ae1a-31fdd6db88512
968497tobacco leaf allergenic extract 20 MG/mL Injectable SolutionPSNd71013ab-718c-4cb0-ae1a-31fdd6db88512
889598tobacco leaf allergenic extract 50 MG/mL Injectable SolutionPSNd71013ab-718c-4cb0-ae1a-31fdd6db88512
966928cotton fiber allergenic extract 50 MG/ML Injectable SolutionSCDd71013ab-718c-4cb0-ae1a-31fdd6db88512
1014199jute fiber allergenic extract 50 MG/ML Injectable SolutionSCDd71013ab-718c-4cb0-ae1a-31fdd6db88512
904965kapok tree fiber allergenic extract 50 MG/ML Injectable SolutionSCDd71013ab-718c-4cb0-ae1a-31fdd6db88512
852547orris root allergenic extract 100 MG/ML Injectable SolutionSCDd71013ab-718c-4cb0-ae1a-31fdd6db88512
1098356orris root allergenic extract 50 MG/ML Injectable SolutionSCDd71013ab-718c-4cb0-ae1a-31fdd6db88512
967973Pyrethrum cinerariifolium allergenic extract 50 MG/ML Injectable SolutionSCDd71013ab-718c-4cb0-ae1a-31fdd6db88512
852065tobacco leaf allergenic extract 100 MG/ML Injectable SolutionSCDd71013ab-718c-4cb0-ae1a-31fdd6db88512
968497tobacco leaf allergenic extract 20 MG/ML Injectable SolutionSCDd71013ab-718c-4cb0-ae1a-31fdd6db88512
889598tobacco leaf allergenic extract 50 MG/ML Injectable SolutionSCDd71013ab-718c-4cb0-ae1a-31fdd6db88512
904965Ceiba pentandra fiber allergenic extract 0.05 GM/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
1014199Corcorus capsularis fiber extract 0.05 GM/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
1014199Corcorus capsularis fiber extract 50 MG/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
966928cotton fiber allergenic extract 0.05 GM/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
966928cotton fiber extract 50 MG/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
1098356Iris germanica var. florentina root allergenic extract 0.05 GM/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
1098356Iris germanica var. florentina root allergenic extract 1 GM per 20 ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
852547Iris germanica var. florentina root extract 0.1 GM/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
1098356Iris germanica var. florentina root extract 50 MG/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
904965kapok tree fiber extract 5 MG/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
968497Nicotiana tabacum leaf extract 0.02 GM/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
889598Nicotiana tabacum leaf extract 0.05 GM/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
852065Nicotiana tabacum leaf extract 0.1 GM/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
852065Nicotiana tabacum leaf extract 100 MG/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
968497Nicotiana tabacum leaf extract 20 MG/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
889598Nicotiana tabacum leaf extract 50 MG/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
852547orris root extract 0.1 GM/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
852547orris root extract 100 MG/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
967973Pyrethrum cinerariifolium extract 0.05 GM/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
967973Tanacetum cinerariifolium extract 0.05 GM/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512
967973Tanacetum cinerariifolium extract 50 MG/ML Injectable SolutionSYd71013ab-718c-4cb0-ae1a-31fdd6db88512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49288-0403-1492880403012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
49288-0403-2492880403025 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
49288-0403-34928804030310 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
49288-0403-44928804030430 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
49288-0403-54928804030550 mL in 1 VIAL, MULTI-DOSE50 mlHistorical