FDA.reportPublic FDA data

Itraconazole

Product NDC
16714-743
11-digit product format
167140743
Labeler code
16714
Product ID
16714-743_62530d1a-98c7-4605-a95e-4bdf1b4f3d7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Itraconazole
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA208591
Marketing category
ANDA
Marketing start
2017-09-01
Substance
ITRACONAZOLE
Active strength
100 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Itraconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ITRACONAZOLE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii304NUG5GF4
Rxcui311204

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9d9fdd44-2f2e-2968-36a7-2e5aa5ad971eProduct name420210511
177ecfe5-1d67-dab4-615e-cac2b457a3c1Product name820191002
9d180e3e-4d31-448b-8857-92c67ed2461aProduct name120190410
7ac2304e-2df8-d230-3b61-1cd07aab1554Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-743-01Itraconazole4 in 1 BLISTER PACKCAPSULE, COATED PELLETS47
16714-743-01Itraconazole7 in 1 CARTONCAPSULE, COATED PELLETS77
16714-743-02Itraconazole30 in 1 BOTTLECAPSULE, COATED PELLETS307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-743-02EA - Each16714-743191b4a1a-263f-46da-b853-e05cc1fe25e112018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-743ITRACONAZOLE CAPSULE, COATED PELLETS [NORTHSTAR RXLLC]7Current NDC, Legacy NDC, 3 package rows20231227_46732a10-1f0d-4022-9689-256c44683e96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311204itraconazole 100 MG Oral CapsulePSN46732a10-1f0d-4022-9689-256c44683e967
311204itraconazole 100 MG Oral CapsuleSCD46732a10-1f0d-4022-9689-256c44683e967
311204ICNZ 100 MG Oral CapsuleSY46732a10-1f0d-4022-9689-256c44683e967

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-743-01167140743017 BLISTER PACK in 1 CARTON (16714-743-01) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK7 blister pack2017-09-010000-00-00NoNoCurrent
16714-743-021671407430230 CAPSULE, COATED PELLETS in 1 BOTTLE (16714-743-02) 2017-09-010000-00-00NoNoCurrent