FDA.reportPublic FDA data

Parakeet Feather

Product NDC
49288-0390
11-digit product format
492880390
Labeler code
49288
Product ID
49288-0390_1d474d27-4ce9-4bf6-b468-4a92281edc72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Parakeet Feather
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
MELOPSITTACUS UNDULATUS FEATHER
Active strength
0 g/mL
Pharmacologic classes
Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [CS],Allergens [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
49288-0390-12019-10-21C16284748780-1956f9ecf-da52-621f-e053-dbdaa90a74adAllergenic Extract
49288-0390-22019-10-21C16284748780-1956f9ecf-da52-621f-e053-dbdaa90a74adAllergenic Extract
49288-0390-32019-10-21C16284748780-1956f9ecf-da52-621f-e053-dbdaa90a74adAllergenic Extract
49288-0390-42019-10-21C16284748780-1956f9ecf-da52-621f-e053-dbdaa90a74adAllergenic Extract
49288-0390-52019-10-21C16284748780-1956f9ecf-da52-621f-e053-dbdaa90a74adAllergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49288-0390-1Parakeet Feather2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION21
49288-0390-2Parakeet Feather5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION51
49288-0390-3Parakeet Feather10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION101
49288-0390-4Parakeet Feather30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION301
49288-0390-5Parakeet Feather50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOPSITTACUS UNDULATUS FEATHERACTIVE INGREDIENT1XY644QKWGPARAKEET FEATHER INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
MELOPSITTACUS UNDULATUS FEATHERACTIVE MOIETY1XY644QKWGPARAKEET FEATHER INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPARAKEET FEATHER INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOPARAKEET FEATHER INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPARAKEET FEATHER INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPARAKEET FEATHER INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49288-0390PARAKEET FEATHER INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1Legacy NDC, 5 package rows20091215_eb2f0512-0060-4508-a4ea-2ddd73396cdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1192991parakeet feather allergenic extract 20 MG/ML Injectable SolutionPSNeb2f0512-0060-4508-a4ea-2ddd73396cdd1
1192991parakeet feather allergenic extract 20 MG/ML Injectable SolutionSCDeb2f0512-0060-4508-a4ea-2ddd73396cdd1
1192991Melopsittacus undulatus feather extract 0.02 GM/ML Injectable SolutionSYeb2f0512-0060-4508-a4ea-2ddd73396cdd1
1192991Melopsittacus undulatus feather extract 20 MG/ML Injectable SolutionSYeb2f0512-0060-4508-a4ea-2ddd73396cdd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49288-0390-1492880390012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
49288-0390-2492880390025 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
49288-0390-34928803900310 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
49288-0390-44928803900430 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
49288-0390-54928803900550 mL in 1 VIAL, MULTI-DOSE50 mlHistorical