Home NDC 63545-631 Biotitum
Product NDC 63545-631
11-digit product format 635450631
Labeler code 63545
Product ID 63545-631_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 12 [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 Ingredient Strength BIOTIN 12 [hp_C]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6SO6U10H04 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63545-631-01 Biotitum 200 in 1 VIAL, GLASS PELLET 200 1 63545-631-02 Biotitum 1200 in 1 BOTTLE, GLASS PELLET 1200 1 63545-631-03 Biotitum 4000 in 1 BOTTLE, GLASS PELLET 4000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63545-631 BIOTITUM PELLET [HAHNEMANN LABORATORIES, INC.] 1 Current NDC, Legacy NDC, 3 package rows 20220510_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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63545-631-01 63545063101 200 PELLET in 1 VIAL, GLASS (63545-631-01) 200 pellet 2022-05-09 0000-00-00 No No Current 63545-631-02 63545063102 1200 PELLET in 1 BOTTLE, GLASS (63545-631-02) 1200 pellet 2022-05-09 0000-00-00 No No Current 63545-631-03 63545063103 4000 PELLET in 1 BOTTLE, GLASS (63545-631-03) 4000 pellet 2022-05-09 0000-00-00 No No Current