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

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
A208703-001THIAMINE HYDROCHLORIDETHIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208703-001AP

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 06:07:402026-07A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-205c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208703-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2022-04-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208703-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208703-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208703-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208703-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208703-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208703-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208703-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208703-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208703-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208703-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208703-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208703-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208703-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208703-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208703-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208703-001AP15c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208703-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208703-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208703-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208703-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208703-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208703-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208703-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208703-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208703-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208703-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208703-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208703-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208703-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208703-001AP1a50c72e98297…

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
4985bf3c-abe5-4bbb-9dcc-6de387d36d6bAvailable 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
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

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 HYDROCHLORIDEEugia US LLC4985bf3c-abe5-4bbb-9dcc-6de387d36d6b2025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208703
application number: ANDA208703
ndc (product): 55150-273

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