Biotitum

Product NDC
63545-630
11-digit product format
635450630
Labeler code
63545
Product ID
63545-630_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
6 [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
BIOTIN6 [hp_C]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6SO6U10H04Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
de9c9f85-221a-18d2-e053-2a95a90a3c69Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63545-630-01Biotitum200 in 1 VIAL, GLASSPELLET2001
63545-630-02Biotitum1200 in 1 BOTTLE, GLASSPELLET12001
63545-630-03Biotitum4000 in 1 BOTTLE, GLASSPELLET40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63545-630BIOTITUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 3 package rows20220510_de9c9f85-221a-18d2-e053-2a95a90a3c69.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BiotitumBIOTITUMHahnemann Laboratories, INC.de9c9f85-221a-18d2-e053-2a95a90a3c692022-05-09Exact identifier
ndc (product): 63545-630

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63545-630-0163545063001200 PELLET in 1 VIAL, GLASS (63545-630-01) 200 pellet2022-05-090000-00-00NoNoCurrent
63545-630-02635450630021200 PELLET in 1 BOTTLE, GLASS (63545-630-02) 1200 pellet2022-05-090000-00-00NoNoCurrent
63545-630-03635450630034000 PELLET in 1 BOTTLE, GLASS (63545-630-03) 4000 pellet2022-05-090000-00-00NoNoCurrent