FDA.reportPublic FDA data

Chlorpromazine Hydrochloride

Product NDC
0832-0301
11-digit product format
008320301
Labeler code
0832
Product ID
0832-0301_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
ANDA084112
Marketing category
ANDA
Marketing start
2011-08-03
Marketing end
0000-00-00
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
25 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
0832-0301-00EA - Each0832-0301bc245f24-2480-4aa1-8078-645b5bf3c3a512012-07-24
0832-0301-10EA - Each0832-03016c3f02a9-afae-473e-ab62-8bd8c5bfc26b12012-07-24
0832-0301-89EA - Each0832-030102da44ca-1623-49ae-a3a1-b63be0e7a26612016-08-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPROMAZINE HYDROCHLORIDEACTIVE INGREDIENT9WP59609J6CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]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 [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 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
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
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
991194chlorproMAZINE HCl 25 MG Oral TabletPSN509938d5-2658-4840-96ef-d1d892fcdab913
991194chlorpromazine hydrochloride 25 MG Oral TabletSCD509938d5-2658-4840-96ef-d1d892fcdab913
991194chlorproMAZINE HCl 25 MG Oral TabletPSNf2f6ab54-5bab-4fa7-a7ac-0ec3bbc75bfd2
991194chlorpromazine hydrochloride 25 MG Oral TabletSCDf2f6ab54-5bab-4fa7-a7ac-0ec3bbc75bfd2
991044chlorproMAZINE HCl 100 MG Oral TabletPSN33c01749-ef88-4e9c-8b45-0f026af1d5fd1
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
991044chlorpromazine hydrochloride 100 MG Oral TabletSCD33c01749-ef88-4e9c-8b45-0f026af1d5fd1
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0301-0000832030100100 TABLET, SUGAR COATED in 1 BOTTLE (0832-0301-00) 2011-08-030000-00-00NoNoCurrent
0832-0301-0100832030101100 BLISTER PACK in 1 CARTON (0832-0301-01) > 1 TABLET, SUGAR COATED in 1 BLISTER PACK (0832-0301-89) 100 blister pack2016-07-080000-00-00NoNoCurrent
0832-0301-10008320301101000 TABLET, SUGAR COATED in 1 BOTTLE (0832-0301-10) 2011-08-030000-00-00NoNoCurrent