FDA.reportPublic FDA data

CHLORPROMAZINE HYDROCHLORIDE

Product NDC
55150-319
11-digit product format
551500319
Labeler code
55150
Product ID
55150-319_de29daf4-7c8a-4b37-b33c-e9f34f3a14c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORPROMAZINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Eugia US LLC
Application
ANDA211816
Marketing category
ANDA
Marketing start
2020-07-07
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
25 mg/mL
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 HYDROCHLORIDE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9WP59609J6
Rxcui1730076, 1730078

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4907e598-fa92-6444-8b2a-22992506f30aProduct name720260202
78470689-2901-bec5-3fa3-182378bb1540Product name320250124
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a347b2b0-0f41-4d16-ac0d-358db7d523f1Product name120220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-319-01CHLORPROMAZINE HYDROCHLORIDE2 mL in 1 AMPULEINJECTION27
55150-319-25CHLORPROMAZINE HYDROCHLORIDE25 in 1 CARTONINJECTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-319CHLORPROMAZINE HYDROCHLORIDE INJECTION [EUGIA US LLC]4Current NDC, Legacy NDC, 2 package rows20240727_07e6144a-b460-4887-b8e2-dd371c14a55c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730076chlorproMAZINE HCl 25 MG in 1 ML InjectionPSN07e6144a-b460-4887-b8e2-dd371c14a55c7
1730078chlorproMAZINE HCl 50 MG in 2 ML InjectionPSN07e6144a-b460-4887-b8e2-dd371c14a55c7
17300761 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCD07e6144a-b460-4887-b8e2-dd371c14a55c7
17300782 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCD07e6144a-b460-4887-b8e2-dd371c14a55c7
1730076chlorpromazine HCl 25 MG per 1 ML InjectionSY07e6144a-b460-4887-b8e2-dd371c14a55c7
1730078chlorpromazine HCl 50 MG per 2 ML InjectionSY07e6144a-b460-4887-b8e2-dd371c14a55c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-319-01551500319012 mL in 1 AMPULE2 mlHistorical
55150-319-255515003192525 AMPULE in 1 CARTON (55150-319-25) / 2 mL in 1 AMPULE (55150-319-01) 25 ampule2020-07-070000-00-00NoNoCurrent