Home NDC 54288-158 Trimethobenzamide Hydrochloride
Product NDC 54288-158
11-digit product format 542880158
Labeler code 54288
Product ID 54288-158_42fc93e7-da90-4fcf-8b63-3c0a51627b92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trimethobenzamide Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler BPI Labs, LLC
Application ANDA219606
Marketing category ANDA
Marketing start 2026-07-01
Substance TRIMETHOBENZAMIDE HYDROCHLORIDE
Active strength 100 mg/mL
Pharmacologic classes Antiemetic [EPC], Emesis Suppression [PE]
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 A219606-001 TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2025-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219606-001 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 A219606-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2025-10-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219606-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2025-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219606-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2025-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219606-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2025-10-16 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219606-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2025-10-16 a50c72e98297…
Observed Orange Book normalized TE history# 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 Trimethobenzamide Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WDQ5P1SX7Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726680 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 54288-158-25 54288015825 25 VIAL, SINGLE-DOSE in 1 CARTON (54288-158-25) / 2 mL in 1 VIAL, SINGLE-DOSE 2026-07-01 No No Current