FDA.reportPublic FDA data

Thiamine Hydrochloride

Product NDC
55150-273
11-digit product format
551500273
Labeler code
55150
Product ID
55150-273_b4f91191-9bfa-41ed-a9ca-221cf44ffc27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Thiamine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA208703
Marketing category
ANDA
Marketing start
2022-04-20
Substance
THIAMINE HYDROCHLORIDE
Active strength
200 mg/2mL
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 HYDROCHLORIDE200 mg/2mL

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
55150-273-01Thiamine Hydrochloride2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION24
55150-273-25Thiamine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-273-01ML - Milliliter55150-273ab5c7a25-b1e2-4f40-9f23-1e5aa25ae5ab12022-10-06
55150-273-25ML - Milliliter55150-273b9459d8b-50e2-4155-8b6d-248557fb3f8612022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-273THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]3Current NDC, Legacy NDC, 2 package rows20240521_4985bf3c-abe5-4bbb-9dcc-6de387d36d6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSN4985bf3c-abe5-4bbb-9dcc-6de387d36d6b4
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCD4985bf3c-abe5-4bbb-9dcc-6de387d36d6b4
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSY4985bf3c-abe5-4bbb-9dcc-6de387d36d6b4
313324vitamin B 1 100 MG/ML Injectable SolutionSY4985bf3c-abe5-4bbb-9dcc-6de387d36d6b4
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSY4985bf3c-abe5-4bbb-9dcc-6de387d36d6b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-273-01551500273012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
55150-273-255515002732525 VIAL, MULTI-DOSE in 1 CARTON (55150-273-25) / 2 mL in 1 VIAL, MULTI-DOSE (55150-273-01) 2022-04-200000-00-00NoNoCurrent