Promethazine Hydrochloride

Product NDC
67296-0198
11-digit product format
672960198
Labeler code
67296
Product ID
67296-0198_b8d03810-88be-d272-e053-2a95a90aa617
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040596
Marketing category
ANDA
Marketing start
2019-01-01
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
2022-12-31
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
67296-0198-12024-06-13C16284748780-1f386c64a-0268-0266-e053-dadaa90a7c1aPromethazine 25mg
67296-0198-22024-06-13C16284748780-1f386c64a-0268-0266-e053-dadaa90a7c1aPromethazine 25mg
67296-0198-12023-01-30C16284748780-1f386c64a-0268-0266-e053-dadaa90a7c1aPromethazine 25mg
67296-0198-22023-01-30C16284748780-1f386c64a-0268-0266-e053-dadaa90a7c1aPromethazine 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0198-1Promethazine Hydrochloride15 in 1 BOTTLETABLET155
67296-0198-2Promethazine Hydrochloride20 in 1 BOTTLETABLET205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0198PROMETHAZINE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]5Legacy NDC, 2 package rows20240615_891a74cf-c4df-975d-e053-2a95a90a6872.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN891a74cf-c4df-975d-e053-2a95a90a68725
992447promethazine hydrochloride 25 MG Oral TabletSCD891a74cf-c4df-975d-e053-2a95a90a68725

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0198-16729601980115 TABLET in 1 BOTTLE (67296-0198-1) 15 tablet2019-01-010000-00-00NoNoCurrent
67296-0198-26729601980220 TABLET in 1 BOTTLE (67296-0198-2) 20 tablet2019-01-010000-00-00NoNoCurrent