PROMETHAZINE HYDROCHLORIDE

Product NDC
61919-630
11-digit product format
619190630
Labeler code
61919
Product ID
61919-630_9cac9b3f-a50f-0219-e053-2995a90aadbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040863
Marketing category
ANDA
Marketing start
2016-03-02
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
2021-12-31
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
61919-630-102022-01-28C16284748780-1d6a99b39-ee41-a426-e053-dadaa90af4c2PROMETHAZINE HYDROCHLORIDE 25mg
61919-630-602020-01-31C16284748780-19d75b9d0-e257-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-630-10PROMETHAZINE HYDROCHLORIDE10 in 1 BOTTLETABLET102
61919-630-60PROMETHAZINE HYDROCHLORIDE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-630-10EA - Each61919-630fad25e38-6a94-485e-96cf-fced51e3d11d12016-09-02
61919-630-60EA - Each61919-6306315556c-a791-4b2d-bb62-6decb572260712016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-630PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]2Legacy NDC, 1 package rows20200130_2ebb4414-e3f4-3d8d-e054-00144ff88e88.zip
61919-630PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]1Legacy NDC, 1 package rows20160222_2c5d4ccc-5d67-0329-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN2ebb4414-e3f4-3d8d-e054-00144ff88e882
992447promethazine hydrochloride 25 MG Oral TabletSCD2ebb4414-e3f4-3d8d-e054-00144ff88e882
992447promethazine HCl 25 MG Oral TabletPSN2c5d4ccc-5d67-0329-e054-00144ff88e881
992447promethazine hydrochloride 25 MG Oral TabletSCD2c5d4ccc-5d67-0329-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-630-106191906301010 TABLET in 1 BOTTLE (61919-630-10) 10 tablet2016-03-020000-00-00NoNoCurrent
61919-630-606191906306060 in 1 BOTTLEHistorical