Trimethobenzamide Hydrochloride

Product NDC
62135-773
11-digit product format
621350773
Labeler code
62135
Product ID
62135-773_45ae3fa0-7a27-4f11-e063-6294a90a0f67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trimethobenzamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA205950
Marketing category
ANDA
Marketing start
2023-11-21
Substance
TRIMETHOBENZAMIDE HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trimethobenzamide Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIMETHOBENZAMIDE HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWDQ5P1SX7Q
Rxcui860771

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5cb11add-3f77-4e14-9823-b8ca5e31d965Product name120250804

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-773-30Trimethobenzamide Hydrochloride30 in 1 PACKAGECAPSULE302
62135-773-90Trimethobenzamide Hydrochloride90 in 1 PACKAGECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-773-30EA - Each62135-77366c3835e-8ce5-4786-8fb4-0bb2f381928312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-773TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [CHARTWELL RX, LLC]1Current NDC, 2 package rows20231128_ee626da9-cffc-4bb9-a528-482687201b2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860771trimethobenzamide HCl 300 MG Oral CapsulePSNee626da9-cffc-4bb9-a528-482687201b2a2
860771trimethobenzamide hydrochloride 300 MG Oral CapsuleSCDee626da9-cffc-4bb9-a528-482687201b2a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-773-306213507733030 CAPSULE in 1 PACKAGE (62135-773-30) 30 capsule2023-11-21NoNoCurrent
62135-773-906213507739090 CAPSULE in 1 PACKAGE (62135-773-90) 90 capsule2023-11-21NoNoCurrent