Bile Acids Combination

Product NDC
63083-9319
11-digit product format
630839319
Labeler code
63083
Product ID
63083-9319_298326d6-fa06-4c93-b738-89dddf3b6684
Type
HUMAN OTC DRUG
Nonproprietary name
Bile Acids Combination
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
AMARYLLIS BELLADONNA WHOLE; BILIRUBIN; BOS TAURUS BILE; CHELIDONIUM MAJUS WHOLE
Active strength
10; 14; 10; 10 [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bile Acids Combination
Brand name suffix
9319
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMARYLLIS BELLADONNA WHOLE10 [hp_X]/29.5mL
BILIRUBIN14 [hp_X]/29.5mL
BOS TAURUS BILE10 [hp_X]/29.5mL
CHELIDONIUM MAJUS WHOLE10 [hp_X]/29.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii11B89M58UN, RFM9X3LJ49, ET3651ZLOU, 7E889U5RNN

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9319-12026-01-08C16284748780-11030e364-ff0b-111a-e063-dadaa90a10e2R319
63083-9319-12026-01-08C16284748780-11030e364-ff0b-111a-e063-dadaa90a10e2R319
63083-9319-12024-01-30C16284748780-11030e364-ff0b-111a-e063-dadaa90a10e2R319
63083-9319-12024-01-30C16284748780-11030e364-ff0b-111a-e063-dadaa90a10e2R319

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9319-1Bile Acids Combination931929.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-9319BILE ACIDS COMBINATION 9319 (BILE ACIDS COMBINATION) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220211_aeca1d0e-4476-418f-ae46-f1055609659b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-9319-16308393190129.5 mL in 1 BOTTLE, DROPPER (63083-9319-1) 29.5 ml1985-08-150000-00-00NoNoCurrent