Promethazine Hydrochloride

Product NDC
52959-534
11-digit product format
529590534
Labeler code
52959
Product ID
52959-534_d6d3bcd7-acb0-47a0-a19c-33be09363bb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA040596
Marketing category
ANDA
Marketing start
2005-12-14
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-534-002019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-012019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-022019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-102019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-122019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-152019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-202019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-242019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-282019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-302019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-452019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-602019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP
52959-534-902019-11-13C16284748780-197449f38-bf33-f6ea-e053-dbdaa90aa703Promethazine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-534-00Promethazine Hydrochloride100 in 1 BOTTLETABLET1002
52959-534-01Promethazine Hydrochloride120 in 1 BOTTLETABLET1202
52959-534-02Promethazine Hydrochloride2 in 1 BOTTLETABLET22
52959-534-10Promethazine Hydrochloride10 in 1 BOTTLETABLET102
52959-534-12Promethazine Hydrochloride12 in 1 BOTTLETABLET122
52959-534-15Promethazine Hydrochloride15 in 1 BOTTLETABLET152
52959-534-20Promethazine Hydrochloride20 in 1 BOTTLETABLET202
52959-534-24Promethazine Hydrochloride24 in 1 BOTTLETABLET242
52959-534-28Promethazine Hydrochloride28 in 1 BOTTLETABLET282
52959-534-30Promethazine Hydrochloride30 in 1 BOTTLETABLET302
52959-534-45Promethazine Hydrochloride45 in 1 BOTTLETABLET452
52959-534-60Promethazine Hydrochloride60 in 1 BOTTLETABLET602
52959-534-90Promethazine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-534PROMETHAZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 13 package rows20120420_01b3a05f-6002-4cf9-96ac-ff0eed8a196c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN01b3a05f-6002-4cf9-96ac-ff0eed8a196c2
992447promethazine hydrochloride 25 MG Oral TabletSCD01b3a05f-6002-4cf9-96ac-ff0eed8a196c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-534-0052959053400100 in 1 BOTTLEHistorical
52959-534-0152959053401120 in 1 BOTTLEHistorical
52959-534-02529590534022 in 1 BOTTLEHistorical
52959-534-105295905341010 in 1 BOTTLEHistorical
52959-534-125295905341212 in 1 BOTTLEHistorical
52959-534-155295905341515 in 1 BOTTLEHistorical
52959-534-205295905342020 in 1 BOTTLEHistorical
52959-534-245295905342424 in 1 BOTTLEHistorical
52959-534-285295905342828 in 1 BOTTLEHistorical
52959-534-305295905343030 in 1 BOTTLEHistorical
52959-534-455295905344545 in 1 BOTTLEHistorical
52959-534-605295905346060 in 1 BOTTLEHistorical
52959-534-905295905349090 in 1 BOTTLEHistorical