FDA.reportPublic FDA data

Chlorpromazine hydrochloride

Product NDC
73043-048
11-digit product format
730430048
Labeler code
73043
Product ID
73043-048_4635d706-5e3d-4817-bf04-802a20f72a70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Devatis, Inc.
Application
ANDA218229
Marketing category
ANDA
Marketing start
2024-11-01
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
25 mg/mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorpromazine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPROMAZINE HYDROCHLORIDE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9WP59609J6
Rxcui1730076, 1730078

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4907e598-fa92-6444-8b2a-22992506f30aProduct name720260202
78470689-2901-bec5-3fa3-182378bb1540Product name320250124
a347b2b0-0f41-4d16-ac0d-358db7d523f1Product name120220110
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73043-048-01Chlorpromazine hydrochloride1 mL in 1 AMPULEINJECTION12
73043-048-25Chlorpromazine hydrochloride25 in 1 CARTONINJECTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73043-048-01ML - Milliliter73043-0483cdce0f3-073a-4e93-be64-5b12929a2e1812025-05-14
73043-048-25ML - Milliliter73043-0483510586c-b88f-4438-b9ae-f548214d434812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73043-048CHLORPROMAZINE HYDROCHLORIDE INJECTION [DEVATIS, INC.]2Current NDC, 2 package rows20250316_b73b9044-7132-41b7-83d4-2d135ea831f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730076chlorproMAZINE HCl 25 MG in 1 ML InjectionPSNb73b9044-7132-41b7-83d4-2d135ea831f12
1730078chlorproMAZINE HCl 50 MG in 2 ML InjectionPSNb73b9044-7132-41b7-83d4-2d135ea831f12
17300761 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCDb73b9044-7132-41b7-83d4-2d135ea831f12
17300782 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCDb73b9044-7132-41b7-83d4-2d135ea831f12
1730076chlorpromazine HCl 25 MG per 1 ML InjectionSYb73b9044-7132-41b7-83d4-2d135ea831f12
1730078chlorpromazine HCl 50 MG per 2 ML InjectionSYb73b9044-7132-41b7-83d4-2d135ea831f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73043-048-01730430048011 mL in 1 AMPULE1 mlHistorical
73043-048-257304300482525 AMPULE in 1 CARTON (73043-048-25) / 1 mL in 1 AMPULE (73043-048-01) 25 ampule2024-11-01NoNoHistorical