PROMETHAZINE HYDROCHLORIDE

Product NDC
45865-592
11-digit product format
458650592
Labeler code
45865
Product ID
45865-592_7df0a51f-ea75-754b-e053-2991aa0a5e6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA040712
Marketing category
ANDA
Marketing start
2006-07-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-592-302025-01-30C16284748780-12cef2736-9271-d83d-e063-dadaa90ab31fPROMETHAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-592-30PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-592PROMETHAZINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20181227_7df0a51f-ea74-754b-e053-2991aa0a5e6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN7df0a51f-ea74-754b-e053-2991aa0a5e6c1
992447promethazine hydrochloride 25 MG Oral TabletSCD7df0a51f-ea74-754b-e053-2991aa0a5e6c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-592-304586505923030 TABLET in 1 BOTTLE (45865-592-30) 30 tablet2018-06-010000-00-00NoNoCurrent