FDA.reportPublic FDA data

Chlorpromazine Hydrochloride

Product NDC
64725-0304
11-digit product format
647250304
Labeler code
64725
Product ID
64725-0304_39bbc251-0443-466d-b10e-7503e844e056
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA084115
Marketing category
ANDA
Marketing start
2011-08-03
Marketing end
0000-00-00
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Phenothiazines [CS],Phenothiazine [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0304-12020-01-31C16284748780-19d75b9d0-919c-f424-e053-dadaa90a57ceChlorpromazine Hydrochloride Tablets, USP 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0304-1Chlorpromazine Hydrochloride100 in 1 BOTTLETABLET, SUGAR COATED1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Chlorpromazine HydrochlorideACTIVE INGREDIENT9WP59609J6CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
ChlorpromazineACTIVE MOIETYU42B7VYA4PCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
ACACIAINACTIVE INGREDIENT5C5403N26OCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
SHELLACINACTIVE INGREDIENT46N107B71OCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
SUCROSEINACTIVE INGREDIENTC151H8M554CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0304CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141110_3ca8da5b-8dd0-404b-b77c-81bb26ddbce3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991188chlorproMAZINE HCl 200 MG Oral TabletPSN3ca8da5b-8dd0-404b-b77c-81bb26ddbce32
991188chlorpromazine hydrochloride 200 MG Oral TabletSCD3ca8da5b-8dd0-404b-b77c-81bb26ddbce32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0304-164725030401100 in 1 BOTTLEHistorical