Oxcarbazepine

Product NDC
0781-6270
11-digit product format
007816270
Labeler code
0781
Product ID
0781-6270_06fea264-7ef7-4b5d-a772-b5d2d016efc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxcarbazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Sandoz Inc
Application
NDA021285
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2001-05-30
Marketing end
0000-00-00
Substance
OXCARBAZEPINE
Active strength
60 mg/mL
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
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
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6270-43ML - Milliliter0781-62709bcaa11b-8b9f-4e1f-993d-f033ba4819c912015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380OXCARBAZEPINE SUSPENSION [SANDOZ INC]3
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380OXCARBAZEPINE SUSPENSION [SANDOZ INC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MOXCARBAZEPINE SUSPENSION [SANDOZ INC]3
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0ROXCARBAZEPINE SUSPENSION [SANDOZ INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXCARBAZEPINE SUSPENSION [SANDOZ INC]3
LEMONINACTIVE INGREDIENT24RS0A988OOXCARBAZEPINE SUSPENSION [SANDOZ INC]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOXCARBAZEPINE SUSPENSION [SANDOZ INC]3
PLUMINACTIVE INGREDIENT67M3EQ6BE1OXCARBAZEPINE SUSPENSION [SANDOZ INC]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOXCARBAZEPINE SUSPENSION [SANDOZ INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXCARBAZEPINE SUSPENSION [SANDOZ INC]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOXCARBAZEPINE SUSPENSION [SANDOZ INC]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYOXCARBAZEPINE SUSPENSION [SANDOZ INC]3
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BOXCARBAZEPINE SUSPENSION [SANDOZ INC]3
SORBITOLINACTIVE INGREDIENT506T60A25ROXCARBAZEPINE SUSPENSION [SANDOZ INC]3
WATERINACTIVE INGREDIENT059QF0KO0ROXCARBAZEPINE SUSPENSION [SANDOZ INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-6270OXCARBAZEPINE SUSPENSION [SANDOZ INC]8Legacy NDC20230714_1ccdb12e-3c52-4fb4-a2db-aeb8ca5757f7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-6270-4300781627043250 mL in 1 BOTTLE (0781-6270-43) 250 ml2001-05-300000-00-00NoNoCurrent