Promethazine Hydrochloride

Product NDC
42254-045
11-digit product format
422540045
Labeler code
42254
Product ID
42254-045_749af379-2de0-4644-ae06-e8b03d863582
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
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
E
Listing certified through
2017-12-31
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
42254-045-10Promethazine Hydrochloride10 in 1 BOTTLETABLET101
42254-045-15Promethazine Hydrochloride15 in 1 BOTTLETABLET151
42254-045-20Promethazine Hydrochloride20 in 1 BOTTLETABLET201
42254-045-30Promethazine Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-045PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20120411_749af379-2de0-4644-ae06-e8b03d863582.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN749af379-2de0-4644-ae06-e8b03d8635821
992447promethazine hydrochloride 25 MG Oral TabletSCD749af379-2de0-4644-ae06-e8b03d8635821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-045-104225400451010 in 1 BOTTLEHistorical
42254-045-154225400451515 in 1 BOTTLEHistorical
42254-045-204225400452020 in 1 BOTTLEHistorical
42254-045-304225400453030 in 1 BOTTLEHistorical