THIAMINE HYDROCHLORIDE

Product NDC
0404-9799
11-digit product format
004049799
Labeler code
0404
Product ID
0404-9799_e120bcda-effd-4f26-a706-47109c40062d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thiamine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA080571
Marketing category
ANDA
Marketing start
2024-09-17
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 HYDROCHLORIDE
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
0404-9799-20THIAMINE HYDROCHLORIDE2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION22
0404-9799-20THIAMINE HYDROCHLORIDE1 in 1 BAGINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9799THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.]1Current NDC, 2 package rows20240925_3bdf3b03-90cf-4416-9344-7733b193adf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSN3bdf3b03-90cf-4416-9344-7733b193adf52
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCD3bdf3b03-90cf-4416-9344-7733b193adf52
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSY3bdf3b03-90cf-4416-9344-7733b193adf52
313324vitamin B 1 100 MG/ML Injectable SolutionSY3bdf3b03-90cf-4416-9344-7733b193adf52
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSY3bdf3b03-90cf-4416-9344-7733b193adf52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0404-9799-20004049799201 VIAL, MULTI-DOSE in 1 BAG (0404-9799-20) / 2 mL in 1 VIAL, MULTI-DOSE2024-09-17NoNoCurrent