FDA.reportPublic FDA data

Chlorpromazine Hydrochloride

Product NDC
0832-0303
11-digit product format
008320303
Labeler code
0832
Product ID
0832-0303_887ebd0c-9fef-47b4-8096-20f67e1de49f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Upsher-Smith Laboratories, Inc.
Application
ANDA084114
Marketing category
ANDA
Marketing start
2011-08-03
Marketing end
0000-00-00
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0303-00EA - Each0832-03038dce22b5-e1c2-494e-864a-7f5095e3cc8012012-07-24
0832-0303-10EA - Each0832-03034ed660ce-f616-4d31-9cef-9b7b0dc372e812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
chlorpromazine hydrochlorideACTIVE INGREDIENT9WP59609J6CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
CHLORPROMAZINE HYDROCHLORIDEACTIVE INGREDIENT9WP59609J6CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
chlorpromazineACTIVE MOIETYU42B7VYA4PCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
CHLORPROMAZINEACTIVE MOIETYU42B7VYA4PCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ACACIAINACTIVE INGREDIENT5C5403N26OCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
acaciaINACTIVE INGREDIENT5C5403N26OCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
calcium sulfateINACTIVE INGREDIENTWAT0DDB505CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
povidoneINACTIVE INGREDIENTFZ989GH94ECHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
sucroseINACTIVE INGREDIENTC151H8M554CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991044chlorproMAZINE HCl 100 MG Oral TabletPSN3b8545ef-312d-4af6-a082-2497b84ff16117
991044chlorpromazine hydrochloride 100 MG Oral TabletSCD3b8545ef-312d-4af6-a082-2497b84ff16117
991044chlorproMAZINE HCl 100 MG Oral TabletPSN33c01749-ef88-4e9c-8b45-0f026af1d5fd1
991044chlorproMAZINE HCl 100 MG Oral TabletPSN533f3ed8-4569-48e2-95ee-efe428896b8d1
991188chlorproMAZINE HCl 200 MG Oral TabletPSN33c01749-ef88-4e9c-8b45-0f026af1d5fd1
991194chlorproMAZINE HCl 25 MG Oral TabletPSN33c01749-ef88-4e9c-8b45-0f026af1d5fd1
991336chlorproMAZINE HCl 50 MG Oral TabletPSN33c01749-ef88-4e9c-8b45-0f026af1d5fd1
991336chlorproMAZINE HCl 50 MG Oral TabletPSN533f3ed8-4569-48e2-95ee-efe428896b8d1
991044chlorpromazine hydrochloride 100 MG Oral TabletSCD33c01749-ef88-4e9c-8b45-0f026af1d5fd1
991044chlorpromazine hydrochloride 100 MG Oral TabletSCD533f3ed8-4569-48e2-95ee-efe428896b8d1
991188chlorpromazine hydrochloride 200 MG Oral TabletSCD33c01749-ef88-4e9c-8b45-0f026af1d5fd1
991194chlorpromazine hydrochloride 25 MG Oral TabletSCD33c01749-ef88-4e9c-8b45-0f026af1d5fd1
991336chlorpromazine hydrochloride 50 MG Oral TabletSCD33c01749-ef88-4e9c-8b45-0f026af1d5fd1
991336chlorpromazine hydrochloride 50 MG Oral TabletSCD533f3ed8-4569-48e2-95ee-efe428896b8d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0303-0000832030300100 TABLET, SUGAR COATED in 1 BOTTLE (0832-0303-00) 2011-08-030000-00-00NoNoCurrent
0832-0303-0100832030301100 BLISTER PACK in 1 CARTON (0832-0303-01) > 1 TABLET, SUGAR COATED in 1 BLISTER PACK (0832-0303-89) 100 blister pack2016-07-080000-00-00NoNoCurrent
0832-0303-10008320303101000 TABLET, SUGAR COATED in 1 BOTTLE (0832-0303-10) 2011-08-030000-00-00NoNoCurrent