Thiamine Hydrochloride

Product NDC
83270-004
11-digit product format
832700004
Labeler code
83270
Product ID
83270-004_5268bd0e-2f42-cbeb-e063-6394a90a3ef8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Thiamine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
ONESOURCE SPECIALTY PHARMA LIMITED
Application
ANDA217181
Marketing category
ANDA
Marketing start
2026-02-27
Substance
THIAMINE HYDROCHLORIDE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Thiamine Hydrochloride
Listing expiration
2027-12-31

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
83270-004-01Thiamine Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION23
83270-004-03Thiamine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83270-004THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED]2Current NDC, 2 package rows20250523_2e957a35-83b3-47f5-ad09-216b22cc30be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSN2e957a35-83b3-47f5-ad09-216b22cc30be3
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCD2e957a35-83b3-47f5-ad09-216b22cc30be3
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSY2e957a35-83b3-47f5-ad09-216b22cc30be3
313324vitamin B 1 100 MG/ML Injectable SolutionSY2e957a35-83b3-47f5-ad09-216b22cc30be3
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSY2e957a35-83b3-47f5-ad09-216b22cc30be3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83270-004-01832700004012 mL in 1 VIAL2 mlHistorical
83270-004-038327000040325 VIAL in 1 CARTON (83270-004-03) / 2 mL in 1 VIAL (83270-004-01) 25 vial2026-02-27NoNoCurrent