thiamine hydrochloride

Product NDC
25021-500
11-digit product format
250210500
Labeler code
25021
Product ID
25021-500_644d12b5-9a05-47dc-9e1c-d8f6fe9bbec2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thiamine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA206106
Marketing category
ANDA
Marketing start
2021-01-20
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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25021-500-022024-01-30C16284748780-11030e365-11ee-111a-e063-dadaa90a10e2Thiamine Hydrochloride Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-500-02thiamine hydrochloride25 in 1 CARTONINJECTION, SOLUTION255
25021-500-02thiamine hydrochloride2 mL in 1 VIALINJECTION, SOLUTION25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-500-02ML - Milliliter25021-500e26077ac-3e82-4212-830d-dc8b49bce7cd12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-500THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20240724_5982cf83-01d6-4acb-8373-339079b8a76e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSN5982cf83-01d6-4acb-8373-339079b8a76e5
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCD5982cf83-01d6-4acb-8373-339079b8a76e5
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSY5982cf83-01d6-4acb-8373-339079b8a76e5
313324vitamin B 1 100 MG/ML Injectable SolutionSY5982cf83-01d6-4acb-8373-339079b8a76e5
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSY5982cf83-01d6-4acb-8373-339079b8a76e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-500-022502105000225 VIAL in 1 CARTON (25021-500-02) / 2 mL in 1 VIAL25 vial2021-01-200000-00-00NoNoCurrent