Thiamine

Product NDC
72485-507
11-digit product format
724850507
Labeler code
72485
Product ID
72485-507_9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Thiamine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA215692
Marketing category
ANDA
Marketing start
2023-05-22
Substance
THIAMINE HYDROCHLORIDE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THIAMINE HYDROCHLORIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM572600E5P
Rxcui313324

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-507-01Thiamine2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION21
72485-507-25Thiamine25 in 1 CARTONINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-507-01ML - Milliliter72485-5075a1c99b3-dd58-4475-b0b3-8f6fed9960fe12023-07-06
72485-507-25ML - Milliliter72485-507799a6678-acfd-4845-9262-0e0c7ec465a312023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-507THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.]1Current NDC, 2 package rows20230526_9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSN9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd91
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCD9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd91
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSY9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd91
313324vitamin B 1 100 MG/ML Injectable SolutionSY9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd91
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSY9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-507-01724850507012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
72485-507-257248505072525 VIAL, MULTI-DOSE in 1 CARTON (72485-507-25) / 2 mL in 1 VIAL, MULTI-DOSE (72485-507-01) 2023-05-22NoNoHistorical