FDA.reportPublic FDA data

CHLORPROMAZINE HYDROCHLORIDE

Product NDC
50268-166
11-digit product format
502680166
Labeler code
50268
Product ID
50268-166_47e24518-b486-ad20-e063-6294a90ad040
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORPROMAZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA209755
Marketing category
ANDA
Marketing start
2020-02-14
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
200 mg/1
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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9WP59609J6
Rxcui991039, 991044, 991188, 991194, 991336

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
50268-166-11CHLORPROMAZINE HYDROCHLORIDE1 in 1 BLISTER PACKTABLET, FILM COATED16
50268-166-12CHLORPROMAZINE HYDROCHLORIDE20 in 1 BOXTABLET, FILM COATED206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-166-11EA - Each50268-1669ddc1edf-881e-4a19-9689-67dd1c3e69f912020-03-10
50268-166-12EA - Each50268-1667b1d93ae-d83f-4b43-a797-d85a9c8899c312020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-166CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]5Current NDC, Legacy NDC, 2 package rows20240110_9e8cebc0-7fcf-dca8-e053-2a95a90a3369.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991039chlorproMAZINE HCl 10 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991044chlorproMAZINE HCl 100 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991188chlorproMAZINE HCl 200 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991194chlorproMAZINE HCl 25 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991336chlorproMAZINE HCl 50 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991039chlorpromazine hydrochloride 10 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991044chlorpromazine hydrochloride 100 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991188chlorpromazine hydrochloride 200 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991194chlorpromazine hydrochloride 25 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991336chlorpromazine hydrochloride 50 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-166-11502680166111 in 1 BLISTER PACKHistorical
50268-166-125026801661220 BLISTER PACK in 1 BOX (50268-166-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-166-11) 20 blister pack2020-02-140000-00-00NoNoCurrent