Chlorpromazine Hydrochloride

Product NDC
0781-4027
11-digit product format
007814027
Labeler code
0781
Product ID
0781-4027_cfff95df-4926-4139-a109-2beebebcf014
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
Sandoz, Inc.
Application
ANDA214542
Marketing category
ANDA
Marketing start
2023-03-31
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9WP59609J6
Rxcui991053, 991332

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-4027-53Chlorpromazine Hydrochloride120 mL in 1 BOTTLE, PLASTICCONCENTRATE1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-4027-53ML - Milliliter0781-4027a7493b86-48fd-4389-aea1-1b30f11fe5bc12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-4027CHLORPROMAZINE HYDROCHLORIDE CONCENTRATE [SANDOZ, INC.]2Current NDC, 1 package rows20230404_9398a0b4-e08b-4eb7-9f31-97d4f384427a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991053chlorproMAZINE HCl 100 MG/mL Oral SolutionPSN9398a0b4-e08b-4eb7-9f31-97d4f384427a3
991332chlorproMAZINE hydrochloride 30 MG/mL Oral SolutionPSN9398a0b4-e08b-4eb7-9f31-97d4f384427a3
991053chlorpromazine hydrochloride 100 MG/ML Oral SolutionSCD9398a0b4-e08b-4eb7-9f31-97d4f384427a3
991332chlorpromazine hydrochloride 30 MG/ML Oral SolutionSCD9398a0b4-e08b-4eb7-9f31-97d4f384427a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-4027-5300781402753120 mL in 1 BOTTLE, PLASTIC (0781-4027-53) 120 ml2023-03-31NoNoHistorical