FDA.reportPublic FDA data

thiamine hydrochloride

Product NDC
68083-567
11-digit product format
680830567
Labeler code
68083
Product ID
68083-567_809c6495-dfc8-4a9e-ab98-9a5e607075ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thiamine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA217800
Marketing category
ANDA
Marketing start
2025-02-24
Substance
THIAMINE HYDROCHLORIDE
Active strength
200 mg/2mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217800-001THIAMINE HYDROCHLORIDETHIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2025-02-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217800-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217800-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2025-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217800-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2025-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217800-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2025-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A217800-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2025-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217800-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2025-02-24fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217800-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2025-02-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217800-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217800-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217800-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217800-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217800-001AP1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217800-001AP1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M572600E5PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313324Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc0265cd-d13a-477c-8c2c-8d44fd86444eAvailable on FDA.report

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
68083-567-25thiamine hydrochloride25 in 1 CARTONINJECTION, SOLUTION253
68083-567-25thiamine hydrochloride2 mL in 1 VIALINJECTION, SOLUTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-567THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED]3Current NDC, 2 package rows20250302_fc0265cd-d13a-477c-8c2c-8d44fd86444e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
thiamine hydrochlorideTHIAMINE HYDROCHLORIDEGland Pharma Limitedfc0265cd-d13a-477c-8c2c-8d44fd86444e2025-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217800
application number: ANDA217800
ndc (product): 68083-567

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSNfc0265cd-d13a-477c-8c2c-8d44fd86444e3
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCDfc0265cd-d13a-477c-8c2c-8d44fd86444e3
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSYfc0265cd-d13a-477c-8c2c-8d44fd86444e3
313324vitamin B 1 100 MG/ML Injectable SolutionSYfc0265cd-d13a-477c-8c2c-8d44fd86444e3
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSYfc0265cd-d13a-477c-8c2c-8d44fd86444e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-567-256808305672525 VIAL in 1 CARTON (68083-567-25) / 2 mL in 1 VIAL25 vial2025-02-24NoNoCurrent