Cholbam

Product NDC
45043-001
11-digit product format
450430001
Labeler code
45043
Product ID
45043-001_83e385b7-54bc-4ee2-b477-4e7524508ee3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cholic Acid
Dosage form
CAPSULE
Route
ORAL
Labeler
Manchester Pharmaceuticals, LLC
Application
NDA205750
Marketing category
NDA
Marketing start
2015-03-31
Marketing end
0000-00-00
Substance
CHOLIC ACID
Active strength
50 mg/1
Pharmacologic classes
Bile Acid [EPC], Bile Acids and Salts [CS]
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
45043-001-02EA - Each45043-0011676d751-f3af-4862-92fb-26faf1b5817a12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cholic AcidACTIVE INGREDIENTG1JO7801AECHOLBAM (CHOLIC ACID) CAPSULE [MANCHESTER PHARMACEUTICALS]1
Cholic AcidACTIVE MOIETYG1JO7801AECHOLBAM (CHOLIC ACID) CAPSULE [MANCHESTER PHARMACEUTICALS]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UCHOLBAM (CHOLIC ACID) CAPSULE [MANCHESTER PHARMACEUTICALS]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30CHOLBAM (CHOLIC ACID) CAPSULE [MANCHESTER PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45043-001CHOLBAM (CHOLIC ACID) CAPSULE [MANCHESTER PHARMACEUTICALS, LLC]9Legacy NDC20230404_e5b67402-8550-4604-97a0-c7b149fbf753.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45043-001-024504300010290 CAPSULE in 1 BOTTLE (45043-001-02) 90 capsule2015-03-310000-00-00NoNoCurrent