FDA.reportPublic FDA data

capecitabine

Product NDC
31722-775
11-digit product format
317220775
Labeler code
31722
Product ID
31722-775_519e85b4-ff10-917f-e063-6394a90a12df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA210203
Marketing category
ANDA
Marketing start
2024-03-05
Substance
CAPECITABINE
Active strength
500 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
capecitabine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPECITABINE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6804DJ8Z9U
Rxcui200327, 200328

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a5eae620-c3a7-41bb-55a8-fce9c3eb9864Product name920180820

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-775-12capecitabine120 in 1 BOTTLETABLET, FILM COATED1203
31722-775-60capecitabine60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-775-12EA - Each31722-775c673c7c0-bea0-4241-9552-31037f314dea12024-10-04
31722-775-60EA - Each31722-775fa9c4b3b-151d-44de-b06e-218fc7428c3212024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-775CAPECITABINE (CAPECITABINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20240423_3e7d6317-1439-4976-ae00-6f62619ec3dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSN3e7d6317-1439-4976-ae00-6f62619ec3dd3
200328capecitabine 500 MG Oral TabletPSN3e7d6317-1439-4976-ae00-6f62619ec3dd3
200327capecitabine 150 MG Oral TabletSCD3e7d6317-1439-4976-ae00-6f62619ec3dd3
200328capecitabine 500 MG Oral TabletSCD3e7d6317-1439-4976-ae00-6f62619ec3dd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-775-1231722077512120 TABLET, FILM COATED in 1 BOTTLE (31722-775-12) 2024-03-05NoNoCurrent
31722-775-603172207756060 TABLET, FILM COATED in 1 BOTTLE (31722-775-60) 2024-04-19NoNoCurrent