FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
21695-589
11-digit product format
216950589
Labeler code
21695
Product ID
21695-589_65b2f396-666b-4b08-890f-19429844e74b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA040596
Marketing category
ANDA
Marketing start
2005-12-14
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
13 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
21695-589-152019-09-24C16284748780-1934fe258-483c-48b1-e053-8cdaa90a720aPromethazine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-589-15Promethazine Hydrochloride15 in 1 BOTTLETABLET151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-589-15EA - Each21695-589ba025b7f-f7c2-4904-8702-f82a03d712ba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-589PROMETHAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_65b2f396-666b-4b08-890f-19429844e74b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992438promethazine HCl 12.5 MG Oral TabletPSN65b2f396-666b-4b08-890f-19429844e74b1
992475promethazine HCl 50 MG Oral TabletPSN65b2f396-666b-4b08-890f-19429844e74b1
992438promethazine hydrochloride 12.5 MG Oral TabletSCD65b2f396-666b-4b08-890f-19429844e74b1
992475promethazine hydrochloride 50 MG Oral TabletSCD65b2f396-666b-4b08-890f-19429844e74b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-589-152169505891515 in 1 BOTTLEHistorical