THIAMINE HYDROCHLORIDE

Product NDC
0404-9963
11-digit product format
004049963
Labeler code
0404
Product ID
0404-9963_cf11a7a8-2864-4682-a335-71cc5591bc48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thiamine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA091623
Marketing category
ANDA
Marketing start
2022-01-12
Marketing end
2026-11-30
Substance
THIAMINE HYDROCHLORIDE
Active strength
100 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
THIAMINE HYDROCHLORIDE

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
0404-9963-02THIAMINE HYDROCHLORIDE1 in 1 BAGINJECTION, SOLUTION16
0404-9963-02THIAMINE HYDROCHLORIDE2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9963THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 2 package rows20240704_c006eca3-137a-493f-bbc4-f04e463d66f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSNc006eca3-137a-493f-bbc4-f04e463d66f96
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCDc006eca3-137a-493f-bbc4-f04e463d66f96
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSYc006eca3-137a-493f-bbc4-f04e463d66f96
313324vitamin B 1 100 MG/ML Injectable SolutionSYc006eca3-137a-493f-bbc4-f04e463d66f96
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSYc006eca3-137a-493f-bbc4-f04e463d66f96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9963-02004049963021 VIAL, MULTI-DOSE in 1 BAG (0404-9963-02) / 2 mL in 1 VIAL, MULTI-DOSE2022-01-122026-11-30NoNoCurrent