Home NDC 42023-119 Tigan
Product NDC 42023-119
11-digit product format 420230119
Labeler code 42023
Product ID 42023-119_1ff4d082-abae-4412-818b-099c8a1e4ede
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trimethobenzamide hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Par Health USA, LLC
Application NDA017530
Marketing category NDA
Marketing start 2008-08-01
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 1 .
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 N017530-001 TIGAN TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N017530-001 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 2026-08-01 22:54:32 2026-06 N017530-001 TIGAN 100MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N017530-001 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Tigan
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726680 Internal RxNorm lookup 1726682 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42023-119-25 Tigan 25 in 1 TRAY INJECTION 25 13 42023-119-25 Tigan 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded trimethobenzamide hydrochloride ACTIVE INGREDIENT WDQ5P1SX7Q TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.] 2 trimethobenzamide ACTIVE MOIETY W2X096QY97 TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.] 2 PHENOL INACTIVE INGREDIENT 339NCG44TV TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.] 2 Trimethobenzamide Hydrochloride ACTIVE INGREDIENT WDQ5P1SX7Q TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 1 Trimethobenzamide ACTIVE MOIETY W2X096QY97 TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-119 TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [ENDO USA, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240913_7da90678-b229-4ad6-9193-2b8a3e9ba695.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42023-119-25 42023011925 25 VIAL, SINGLE-DOSE in 1 TRAY (42023-119-25) / 2 mL in 1 VIAL, SINGLE-DOSE 2008-08-01 0000-00-00 No No Current