FDA.reportPublic FDA data

Chlorpromazine Hydrochloride

Product NDC
0527-2963
11-digit product format
005272963
Labeler code
0527
Product ID
0527-2963_03738900-0fff-440f-bcaa-ec16f7201f6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA212996
Marketing category
ANDA
Marketing start
2021-01-22
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorpromazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPROMAZINE HYDROCHLORIDE50 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a347b2b0-0f41-4d16-ac0d-358db7d523f1Product name120220110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-2963-37Chlorpromazine Hydrochloride100 in 1 BOTTLETABLET, COATED1007
0527-2963-43Chlorpromazine Hydrochloride1000 in 1 BOTTLETABLET, COATED10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-2963-37EA - Each0527-2963ebdee105-dba2-446e-8160-44a5a7f994f012021-03-02
0527-2963-43EA - Each0527-296337d577bf-caf4-4247-a3c0-e1242015617412021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-2963CHLORPROMAZINE HYDROCHLORIDE TABLET, COATED [LANNETT COMPANY, INC.]6Current NDC, Legacy NDC, 2 package rows20220729_1049538a-c012-41bf-932e-3c85f57f9577.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991039chlorproMAZINE HCl 10 MG Oral TabletPSN1049538a-c012-41bf-932e-3c85f57f95777
991044chlorproMAZINE HCl 100 MG Oral TabletPSN1049538a-c012-41bf-932e-3c85f57f95777
991188chlorproMAZINE HCl 200 MG Oral TabletPSN1049538a-c012-41bf-932e-3c85f57f95777
991194chlorproMAZINE HCl 25 MG Oral TabletPSN1049538a-c012-41bf-932e-3c85f57f95777
991336chlorproMAZINE HCl 50 MG Oral TabletPSN1049538a-c012-41bf-932e-3c85f57f95777
991039chlorpromazine hydrochloride 10 MG Oral TabletSCD1049538a-c012-41bf-932e-3c85f57f95777
991044chlorpromazine hydrochloride 100 MG Oral TabletSCD1049538a-c012-41bf-932e-3c85f57f95777
991188chlorpromazine hydrochloride 200 MG Oral TabletSCD1049538a-c012-41bf-932e-3c85f57f95777
991194chlorpromazine hydrochloride 25 MG Oral TabletSCD1049538a-c012-41bf-932e-3c85f57f95777
991336chlorpromazine hydrochloride 50 MG Oral TabletSCD1049538a-c012-41bf-932e-3c85f57f95777
991039chlorproMAZINE HCl 10 MG Oral TabletPSNc212a2a1-323a-8b61-e053-2995a90a5b044
991044chlorproMAZINE HCl 100 MG Oral TabletPSNc212a2a1-323a-8b61-e053-2995a90a5b044
991188chlorproMAZINE HCl 200 MG Oral TabletPSNc212a2a1-323a-8b61-e053-2995a90a5b044
991194chlorproMAZINE HCl 25 MG Oral TabletPSNc212a2a1-323a-8b61-e053-2995a90a5b044
991336chlorproMAZINE HCl 50 MG Oral TabletPSNc212a2a1-323a-8b61-e053-2995a90a5b044
991039chlorpromazine hydrochloride 10 MG Oral TabletSCDc212a2a1-323a-8b61-e053-2995a90a5b044
991044chlorpromazine hydrochloride 100 MG Oral TabletSCDc212a2a1-323a-8b61-e053-2995a90a5b044
991188chlorpromazine hydrochloride 200 MG Oral TabletSCDc212a2a1-323a-8b61-e053-2995a90a5b044
991194chlorpromazine hydrochloride 25 MG Oral TabletSCDc212a2a1-323a-8b61-e053-2995a90a5b044
991336chlorpromazine hydrochloride 50 MG Oral TabletSCDc212a2a1-323a-8b61-e053-2995a90a5b044

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-2963-3700527296337100 TABLET, COATED in 1 BOTTLE (0527-2963-37) 2021-01-220000-00-00NoNoCurrent
0527-2963-43005272963431000 TABLET, COATED in 1 BOTTLE (0527-2963-43) 2021-01-220000-00-00NoNoCurrent