FDA.reportPublic FDA data

Thiamine

Product NDC
65145-129
11-digit product format
651450129
Labeler code
65145
Product ID
65145-129_66c1e502-6c85-43a5-b9a7-76368ebd39bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Thiamine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA215692
Marketing category
ANDA
Marketing start
2024-05-20
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
65145-129-01Thiamine2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION22
65145-129-25Thiamine25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-129-01ML - Milliliter65145-129694916dd-f152-43f9-8b07-a8cee0adf26a12024-10-04
65145-129-25ML - Milliliter65145-1297180f20e-a6f9-485a-9abd-1811a83b789512024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-129THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [CAPLIN STERILES LIMITED]2Current NDC, 2 package rows20240521_8909424c-9d5b-4e35-b2d3-da9d3316a4cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSN8909424c-9d5b-4e35-b2d3-da9d3316a4cc2
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCD8909424c-9d5b-4e35-b2d3-da9d3316a4cc2
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSY8909424c-9d5b-4e35-b2d3-da9d3316a4cc2
313324vitamin B 1 100 MG/ML Injectable SolutionSY8909424c-9d5b-4e35-b2d3-da9d3316a4cc2
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSY8909424c-9d5b-4e35-b2d3-da9d3316a4cc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-129-01651450129012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
65145-129-256514501292525 VIAL, MULTI-DOSE in 1 CARTON (65145-129-25) / 2 mL in 1 VIAL, MULTI-DOSE (65145-129-01) 2024-05-20NoNoHistorical