CHLORPROMAZINE HYDROCHLORIDE

Product NDC
65219-128
11-digit product format
652190128
Labeler code
65219
Product ID
65219-128_64ba1614-82e8-476f-957d-a29198c7a26e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORPROMAZINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Fresenius Kabi USA, LLC
Application
ANDA216724
Marketing category
ANDA
Marketing start
2025-02-15
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
65219-128-00CHLORPROMAZINE HYDROCHLORIDE1 mL in 1 VIALINJECTION11
65219-128-01CHLORPROMAZINE HYDROCHLORIDE25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-128-00ML - Milliliter65219-1289aa45967-2d5b-4a30-8753-6d26d0552fc012025-05-14
65219-128-01ML - Milliliter65219-1289b17cb16-fb38-40e0-bf8d-1b83077302f312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-128CHLORPROMAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]1Current NDC, 2 package rows20250216_5831e15a-3efa-48bb-9d49-8451f78d9868.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730076chlorproMAZINE HCl 25 MG in 1 ML InjectionPSN5831e15a-3efa-48bb-9d49-8451f78d98681
1730078chlorproMAZINE HCl 50 MG in 2 ML InjectionPSN5831e15a-3efa-48bb-9d49-8451f78d98681
17300761 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCD5831e15a-3efa-48bb-9d49-8451f78d98681
17300782 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCD5831e15a-3efa-48bb-9d49-8451f78d98681
1730076chlorpromazine HCl 25 MG per 1 ML InjectionSY5831e15a-3efa-48bb-9d49-8451f78d98681
1730078chlorpromazine HCl 50 MG per 2 ML InjectionSY5831e15a-3efa-48bb-9d49-8451f78d98681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-128-00652190128001 mL in 1 VIAL1 mlHistorical
65219-128-016521901280125 VIAL in 1 CARTON (65219-128-01) / 1 mL in 1 VIAL (65219-128-00) 25 vial2025-02-15NoNoHistorical