FDA.reportPublic FDA data

CURVULARIA

Product NDC
0268-0971
11-digit product format
002680971
Labeler code
0268
Product ID
0268-0971_d22863fa-e919-4cfe-8f8b-984947a46a22
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
CURVULARIA INAEQUALIS
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS; SUBCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1965-01-01
Marketing end
0000-00-00
Substance
CURVULARIA INAEQUALIS
Active strength
20000 [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
No
Listing certified through
2021-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0268-0971-10CURVULARIA10 mL in 1 VIALINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0268-0971-10ML - Milliliter0268-0971cf621d8a-43fe-42ff-870a-31f9cb018fcf12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-0971FIRE ANT (SOLENOPSIS INVICTA) INJECTION, SOLUTION CURVULARIA (CURVULARIA INAEQUALIS) INJECTION, SOLUTION LENSCALE (ATRIPLEX LENTIFORMIS POLLEN) INJECTION, SOLUTION MOSQUITO (CULEX PIPIENS) INJECTION, SOLUTION MIXED COCKROACH (BLATTELLA GERMANICA AND PERIPLANETA AMERICANA) INJECTION, SOLUTION MELALEUCA (MELALEUCA QUINQUENERVIA POLLEN) INJECTION, SOLUTION SORREL/DOCK MIX (RUMEX ACETOSELLA POLLEN AND RUMEX CRISPUS POLLEN) INJECTION, SOLUTION MIXED RAGWEED (AMBROSIA ARTEMISIIFOLIA AND AMBROSIA TRIFIDA POLLEN) INJECTION, SOLUTION SHAGBARK, HICKORY (CARYA OVATA POLLEN) INJECTION, SOLUTION [ALK-ABELLO, INC.]6Legacy NDC, 1 package rows20230601_6eed4dc3-8238-4487-bc98-b709defea665.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1735534American cockroach allergenic extract 50 MG/mL / German cockroach allergenic extract 50 MG/mL Injectable SolutionPSN6eed4dc3-8238-4487-bc98-b709defea6656
903916broad leaved paperbark pollen extract 50 MG/ML Injectable SolutionPSN6eed4dc3-8238-4487-bc98-b709defea6656
999443Curvularia inequalis allergenic extract 20000 UNT/ML Injectable SolutionPSN6eed4dc3-8238-4487-bc98-b709defea6656
1922790giant ragweed pollen extract 20000 UNT/ML / short ragweed pollen extract 20000 UNT/ML Injectable SolutionPSN6eed4dc3-8238-4487-bc98-b709defea6656
852099lens scale pollen extract 50 MG/ML Injectable SolutionPSN6eed4dc3-8238-4487-bc98-b709defea6656
968012red imported fire ant allergenic extract 100 MG/ML Injectable SolutionPSN6eed4dc3-8238-4487-bc98-b709defea6656
899684shagbark hickory pollen extract 100 MG/ML Injectable SolutionPSN6eed4dc3-8238-4487-bc98-b709defea6656
901487sheep sorrel pollen extract 50 MG/ML / yellow dock pollen extract 50 MG/ML Injectable SolutionPSN6eed4dc3-8238-4487-bc98-b709defea6656
1735534American cockroach allergenic extract 50 MG/ML / German cockroach allergenic extract 50 MG/ML Injectable SolutionSCD6eed4dc3-8238-4487-bc98-b709defea6656
903916broad leaved paperbark pollen extract 50 MG/ML Injectable SolutionSCD6eed4dc3-8238-4487-bc98-b709defea6656
999443Curvularia inequalis allergenic extract 20000 UNT/ML Injectable SolutionSCD6eed4dc3-8238-4487-bc98-b709defea6656
1922790giant ragweed pollen extract 20000 UNT/ML / short ragweed pollen extract 20000 UNT/ML Injectable SolutionSCD6eed4dc3-8238-4487-bc98-b709defea6656
852099lens scale pollen extract 50 MG/ML Injectable SolutionSCD6eed4dc3-8238-4487-bc98-b709defea6656
968012red imported fire ant allergenic extract 100 MG/ML Injectable SolutionSCD6eed4dc3-8238-4487-bc98-b709defea6656
899684shagbark hickory pollen extract 100 MG/ML Injectable SolutionSCD6eed4dc3-8238-4487-bc98-b709defea6656
901487sheep sorrel pollen extract 50 MG/ML / yellow dock pollen extract 50 MG/ML Injectable SolutionSCD6eed4dc3-8238-4487-bc98-b709defea6656
1922790Ambrosia artemisiifolia pollen extract 20000 PNU/ML / Ambrosia trifida pollen extract 20000 PNU/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
1922790Ambrosia artemisiifolia pollen extract 20000 UNT/ML / Ambrosia trifida pollen extract 20000 UNT/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
852099Atriplex lentiformis pollen extract 0.05 GM/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
852099Atriplex lentiformis pollen extract 50 MG/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
899684Carya ovata pollen extract 0.1 GM/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
899684Carya ovata pollen extract 100 MG/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
999443Curvularia inaequalis extract 20,000 UNT/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
903916Melaleuca quinquenervia pollen extract 0.05 GM/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
903916Melaleuca quinquenervia pollen extract 1:20 Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
903916Melaleuca quinquenervia pollen extract 50 MG/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
1735534Periplaneta americana allergenic extract 0.05 GM/ML / Blatella germanica allergenic extract 0.05 GM/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
903916punktree pollen extract 50 MG/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
901487Rumex acetosella pollen extract 0.05 GM / Rumex crispus pollen extract 0.05 GM per ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
901487Rumex acetosella pollen extract 50 MG / Rumex crispus pollen extract 50 MG per ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
968012Solenopsis invicta allergenic extract 0.1 GM/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656
968012Solenopsis invicta allergenic extract 100 MG/ML Injectable SolutionSY6eed4dc3-8238-4487-bc98-b709defea6656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-0971-100026809711010 mL in 1 VIAL (0268-0971-10) 10 ml1965-01-010000-00-00NoNoCurrent