FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
68001-162
11-digit product format
680010162
Labeler code
68001
Product ID
68001-162_3d817fa0-d0c1-9b87-e063-6394a90af502
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA040596
Marketing category
ANDA
Marketing start
2014-01-13
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Promethazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992438, 992447, 992475

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-162-00Promethazine Hydrochloride100 in 1 BOTTLETABLET1009
68001-162-03Promethazine Hydrochloride500 in 1 BOTTLETABLET5009
68001-162-08Promethazine Hydrochloride1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-162-03EA - Each68001-162fa752381-85c3-454a-8529-012540fcd6e012023-08-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-162PROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]8Current NDC, Legacy NDC, 3 package rows20230906_44cd6d46-fbb9-4836-9426-d8ce2cb6d66d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992438promethazine HCl 12.5 MG Oral TabletPSN44cd6d46-fbb9-4836-9426-d8ce2cb6d66d9
992447promethazine HCl 25 MG Oral TabletPSN44cd6d46-fbb9-4836-9426-d8ce2cb6d66d9
992475promethazine HCl 50 MG Oral TabletPSN44cd6d46-fbb9-4836-9426-d8ce2cb6d66d9
992438promethazine hydrochloride 12.5 MG Oral TabletSCD44cd6d46-fbb9-4836-9426-d8ce2cb6d66d9
992447promethazine hydrochloride 25 MG Oral TabletSCD44cd6d46-fbb9-4836-9426-d8ce2cb6d66d9
992475promethazine hydrochloride 50 MG Oral TabletSCD44cd6d46-fbb9-4836-9426-d8ce2cb6d66d9
992447promethazine HCl 25 MG Oral TabletPSN59b906c6-2ccc-416e-b3ee-db09bf5531463
992447promethazine HCl 25 MG Oral TabletPSN6728bb41-5d50-4abb-bb73-993dcc16ee663
992447promethazine hydrochloride 25 MG Oral TabletSCD59b906c6-2ccc-416e-b3ee-db09bf5531463
992447promethazine hydrochloride 25 MG Oral TabletSCD6728bb41-5d50-4abb-bb73-993dcc16ee663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-162-0068001016200100 TABLET in 1 BOTTLE (68001-162-00) 100 tablet2014-01-130000-00-00NoNoCurrent
68001-162-0368001016203500 TABLET in 1 BOTTLE (68001-162-03) 500 tablet2023-07-27NoNoHistorical
68001-162-08680010162081000 TABLET in 1 BOTTLE (68001-162-08) 1000 tablet2014-01-130000-00-00NoNoCurrent