Home NDC 70756-684 Thiamine Hydrochloride
Product NDC 70756-684
11-digit product format 707560684
Labeler code 70756
Product ID 70756-684_f060a329-8fde-44c1-8750-03b85e478d58
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Thiamine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Lifestar Pharma LLC
Application ANDA220513
Marketing category ANDA
Marketing start 2026-10-01
Substance THIAMINE HYDROCHLORIDE
Active strength 100 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220513-001 THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2026-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220513-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A220513-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2026-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220513-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2026-07-31 caaa826d4ba7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A220513-001 AP 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220513-001 AP 1 caaa826d4ba7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Thiamine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength THIAMINE HYDROCHLORIDE 100 mg/mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70756-684-25 70756068425 25 VIAL, MULTI-DOSE in 1 CARTON (70756-684-25) / 2 mL in 1 VIAL, MULTI-DOSE (70756-684-82) 2026-10-01 No No Current