Promethazine Hydrochloride

Product NDC
50436-0521
11-digit product format
504360521
Labeler code
50436
Product ID
50436-0521_45ceefe8-a361-4d79-92c2-01bf39f4b567
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA091179
Marketing category
ANDA
Marketing start
2011-03-03
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0521-1Promethazine Hydrochloride30 in 1 BOTTLETABLET307
50436-0521-2Promethazine Hydrochloride60 in 1 BOTTLETABLET607
50436-0521-4Promethazine Hydrochloride12 in 1 BOTTLETABLET127
50436-0521-5Promethazine Hydrochloride20 in 1 BOTTLETABLET207
50436-0521-6Promethazine Hydrochloride3 in 1 BOTTLETABLET37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0521PROMETHAZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]7Legacy NDC, 5 package rows20190531_3cf67ac8-05b1-465b-8e57-8640ab6f444e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN3cf67ac8-05b1-465b-8e57-8640ab6f444e7
992447promethazine hydrochloride 25 MG Oral TabletSCD3cf67ac8-05b1-465b-8e57-8640ab6f444e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0521-15043605210130 in 1 BOTTLEHistorical
50436-0521-25043605210260 in 1 BOTTLEHistorical
50436-0521-45043605210412 in 1 BOTTLEHistorical
50436-0521-55043605210520 in 1 BOTTLEHistorical
50436-0521-6504360521063 in 1 BOTTLEHistorical