FDA.reportPublic FDA data

Thiamine Hydrochloride

Product NDC
43598-050
11-digit product format
435980050
Labeler code
43598
Product ID
43598-050_253cd4f8-82f7-be9b-ace6-0e59b3326d88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thiamine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA080571
Marketing category
ANDA
Marketing start
2023-03-31
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-050-11Thiamine Hydrochloride2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION21
43598-050-25Thiamine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-050-11ML - Milliliter43598-0506e190bf6-cbac-4db5-a0e3-00d00c8138c112023-05-05
43598-050-25ML - Milliliter43598-0500e58d79e-c30f-4228-a399-d23069ec263212023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-050THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.]1Current NDC, 2 package rows20230331_43926cec-e483-8cf1-4d8d-5145e554d45d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSN06446e9a-0e85-0623-e063-6294a90ac4034
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCD06446e9a-0e85-0623-e063-6294a90ac4034
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSY06446e9a-0e85-0623-e063-6294a90ac4034
313324vitamin B 1 100 MG/ML Injectable SolutionSY06446e9a-0e85-0623-e063-6294a90ac4034
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSY06446e9a-0e85-0623-e063-6294a90ac4034
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSN3bdf3b03-90cf-4416-9344-7733b193adf52
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCD3bdf3b03-90cf-4416-9344-7733b193adf52
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSY3bdf3b03-90cf-4416-9344-7733b193adf52
313324vitamin B 1 100 MG/ML Injectable SolutionSY3bdf3b03-90cf-4416-9344-7733b193adf52
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSY3bdf3b03-90cf-4416-9344-7733b193adf52
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSN43926cec-e483-8cf1-4d8d-5145e554d45d1
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCD43926cec-e483-8cf1-4d8d-5145e554d45d1
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSY43926cec-e483-8cf1-4d8d-5145e554d45d1
313324vitamin B 1 100 MG/ML Injectable SolutionSY43926cec-e483-8cf1-4d8d-5145e554d45d1
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSY43926cec-e483-8cf1-4d8d-5145e554d45d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-050-11435980050112 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
43598-050-254359800502525 VIAL, MULTI-DOSE in 1 CARTON (43598-050-25) / 2 mL in 1 VIAL, MULTI-DOSE (43598-050-11) 2023-03-31NoNoCurrent