FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Tigan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIMETHOBENZAMIDE HYDROCHLORIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWDQ5P1SX7Q
Rxcui1726680, 1726682

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5cb11add-3f77-4e14-9823-b8ca5e31d965Product name120250804
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-119-25Tigan25 in 1 TRAYINJECTION2513
42023-119-25Tigan2 mL in 1 VIAL, SINGLE-DOSEINJECTION213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-119-25ML - Milliliter42023-11927f21b05-04b4-4db1-ad23-26b53d662b9612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
trimethobenzamide hydrochlorideACTIVE INGREDIENTWDQ5P1SX7QTIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]2
trimethobenzamideACTIVE MOIETYW2X096QY97TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]2
PHENOLINACTIVE INGREDIENT339NCG44TVTIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-119TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [ENDO USA, INC.]8Current NDC, Legacy NDC, 2 package rows20240913_7da90678-b229-4ad6-9193-2b8a3e9ba695.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726682Tigan 200 MG in 2 ML InjectionPSN7da90678-b229-4ad6-9193-2b8a3e9ba69513
1726680trimethobenzamide HCl 200 MG in 2 ML InjectionPSN7da90678-b229-4ad6-9193-2b8a3e9ba69513
17266822 ML trimethobenzamide hydrochloride 100 MG/ML Injection [Tigan]SBD7da90678-b229-4ad6-9193-2b8a3e9ba69513
17266802 ML trimethobenzamide hydrochloride 100 MG/ML InjectionSCD7da90678-b229-4ad6-9193-2b8a3e9ba69513
1726682Tigan 200 MG per 2 ML InjectionSY7da90678-b229-4ad6-9193-2b8a3e9ba69513
1726680trimethobenzamide hydrochloride 200 MG per 2 ML InjectionSY7da90678-b229-4ad6-9193-2b8a3e9ba69513
1726682Tigan 200 MG in 2 ML InjectionPSN147def93-cd3d-4e42-89ad-6a6b413bf3627
1726680trimethobenzamide HCl 200 MG in 2 ML InjectionPSN147def93-cd3d-4e42-89ad-6a6b413bf3627
17266822 ML trimethobenzamide hydrochloride 100 MG/ML Injection [Tigan]SBD147def93-cd3d-4e42-89ad-6a6b413bf3627
17266802 ML trimethobenzamide hydrochloride 100 MG/ML InjectionSCD147def93-cd3d-4e42-89ad-6a6b413bf3627
1726682Tigan 200 MG per 2 ML InjectionSY147def93-cd3d-4e42-89ad-6a6b413bf3627
1726680trimethobenzamide hydrochloride 200 MG per 2 ML InjectionSY147def93-cd3d-4e42-89ad-6a6b413bf3627
1726680trimethobenzamide HCl 200 MG in 2 ML InjectionPSN9bd0bfa0-c189-751c-e053-2a95a90a5f5a4
17266802 ML trimethobenzamide hydrochloride 100 MG/ML InjectionSCD9bd0bfa0-c189-751c-e053-2a95a90a5f5a4
1726680trimethobenzamide hydrochloride 200 MG per 2 ML InjectionSY9bd0bfa0-c189-751c-e053-2a95a90a5f5a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42023-119-254202301192525 VIAL, SINGLE-DOSE in 1 TRAY (42023-119-25) / 2 mL in 1 VIAL, SINGLE-DOSE2008-08-010000-00-00NoNoCurrent