PROMETHAZINE HYDROCHLORIDE

Product NDC
67296-0564
11-digit product format
672960564
Labeler code
67296
Product ID
67296-0564_d5fc2f5d-65ec-8508-e053-2a95a90a65f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
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
2023-12-31
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
67296-0564-12024-07-02C16284748780-11030e365-4ee1-111a-e063-dadaa90a10e240d4ef22-f12f-0667-e054-00144ff8d46c
67296-0564-12024-01-30C16284748780-11030e365-4ee1-111a-e063-dadaa90a10e240d4ef22-f12f-0667-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0564-1PROMETHAZINE HYDROCHLORIDE15 in 1 BOTTLETABLET156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0564PROMETHAZINE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]6Legacy NDC, 1 package rows20240704_40d4ef22-f12f-0667-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN40d4ef22-f12f-0667-e054-00144ff8d46c6
992447promethazine hydrochloride 25 MG Oral TabletSCD40d4ef22-f12f-0667-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0564-16729605640115 TABLET in 1 BOTTLE (67296-0564-1) 15 tablet2006-07-310000-00-00NoNoCurrent