FDA.reportPublic FDA data

Biotitum

Product NDC
63545-632
11-digit product format
635450632
Labeler code
63545
Product ID
63545-632_de9c9f85-221b-18d2-e053-2a95a90a3c69
Type
HUMAN OTC DRUG
Nonproprietary name
Biotitum
Dosage form
PELLET
Route
ORAL
Labeler
Hahnemann Laboratories, INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-05-09
Substance
BIOTIN
Active strength
30 [hp_C]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Biotitum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIOTIN30 [hp_C]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6SO6U10H04

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63545-632-01Biotitum80 in 1 VIAL, GLASSPELLET801
63545-632-02Biotitum200 in 1 VIAL, GLASSPELLET2001
63545-632-03Biotitum1200 in 1 BOTTLE, GLASSPELLET12001
63545-632-04Biotitum4000 in 1 BOTTLE, GLASSPELLET40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63545-632BIOTITUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20220510_de9c9f85-221a-18d2-e053-2a95a90a3c69.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63545-632-016354506320180 PELLET in 1 VIAL, GLASS (63545-632-01) 80 pellet2022-05-090000-00-00NoNoCurrent
63545-632-0263545063202200 PELLET in 1 VIAL, GLASS (63545-632-02) 200 pellet2022-05-090000-00-00NoNoCurrent
63545-632-03635450632031200 PELLET in 1 BOTTLE, GLASS (63545-632-03) 1200 pellet2022-05-090000-00-00NoNoCurrent
63545-632-04635450632044000 PELLET in 1 BOTTLE, GLASS (63545-632-04) 4000 pellet2022-05-090000-00-00NoNoCurrent