Chlorpromazine Hydrochloride

Product NDC
71656-101
11-digit product format
716560101
Labeler code
71656
Product ID
71656-101_4bd1c301-1f67-287b-e063-6294a90ae138
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
Saptalis Pharmaceuticals, LLC.
Application
ANDA080983
Marketing category
ANDA
Marketing start
2026-03-04
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
100 mg/mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPROMAZINE HYDROCHLORIDE100 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
71656-101-08Chlorpromazine Hydrochloride240 mL in 1 BOTTLE, PLASTICCONCENTRATE2402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71656-101-08ML - Milliliter71656-101e6df88ad-489a-4410-bc7d-1bafe2a82db712026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991053chlorproMAZINE HCl 100 MG/mL Oral SolutionPSNcd8f9e23-d08a-4d96-8fe9-35ab2bc861c82
991332chlorproMAZINE hydrochloride 30 MG/mL Oral SolutionPSNcd8f9e23-d08a-4d96-8fe9-35ab2bc861c82
991053chlorpromazine hydrochloride 100 MG/ML Oral SolutionSCDcd8f9e23-d08a-4d96-8fe9-35ab2bc861c82
991332chlorpromazine hydrochloride 30 MG/ML Oral SolutionSCDcd8f9e23-d08a-4d96-8fe9-35ab2bc861c82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71656-101-0871656010108240 mL in 1 BOTTLE, PLASTIC (71656-101-08) 240 ml2026-03-04NoNoCurrent