CAPECITABINE

Product NDC
16714-467
11-digit product format
167140467
Labeler code
16714
Product ID
16714-467_d6937464-feb2-ada0-e053-2a95a90a3aef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CAPECITABINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NORTHSTAR RXLLC
Application
ANDA202593
Marketing category
ANDA
Marketing start
2015-11-01
Marketing end
0000-00-00
Substance
CAPECITABINE
Active strength
150 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-467-01EA - Each16714-4671619846f-2126-4f36-91cd-4289a62569d912016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPECITABINEACTIVE INGREDIENT6804DJ8Z9UCAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1
CAPECITABINEACTIVE MOIETY6804DJ8Z9UCAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-467CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC]6Legacy NDC20241204_7b260da3-dee2-4bbb-9235-39b16720d578.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-467-011671404670160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-467-01) 2015-11-010000-00-00NoNoCurrent