FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
63629-1591
11-digit product format
636291591
Labeler code
63629
Product ID
63629-1591_22f46adc-9086-4db0-8ac9-0f97914b40de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040596
Marketing category
ANDA
Marketing start
2005-12-14
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
12.5 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 HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992438

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
63629-1591-0Promethazine Hydrochloride30 in 1 BOTTLETABLET301023
63629-1591-1Promethazine Hydrochloride12 in 1 BOTTLETABLET121023
63629-1591-2Promethazine Hydrochloride4 in 1 BOTTLETABLET41023
63629-1591-3Promethazine Hydrochloride2 in 1 BOTTLETABLET21023
63629-1591-5Promethazine Hydrochloride6 in 1 BOTTLETABLET61023
63629-1591-6Promethazine Hydrochloride10 in 1 BOTTLETABLET101023
63629-1591-7Promethazine Hydrochloride40 in 1 BOTTLETABLET401023
63629-1591-8Promethazine Hydrochloride20 in 1 BOTTLETABLET201023
63629-1591-9Promethazine Hydrochloride60 in 1 BOTTLETABLET601023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1591-1EA - Each63629-15915a0aa608-8e19-4278-94d2-70c2739dba3212012-07-24
63629-1591-2EA - Each63629-159188adf0f7-8643-4e72-b5d8-ea297103d51f12012-07-24
63629-1591-3EA - Each63629-1591d8eda1d0-5af1-4cd3-a621-38b420fd177f12012-07-24
63629-1591-4EA - Each63629-1591ea969485-0eb8-4f3c-aaf2-117e4eec4c8612012-07-24
63629-1591-5EA - Each63629-15913d3a2dbd-edec-402a-b6c7-b3ffd17065fc12012-07-24
63629-1591-6EA - Each63629-15910d97da75-b080-478e-9a9a-d9ad1ba6df4712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1591PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1023Current NDC, Legacy NDC, 9 package rows20240517_da246971-20b8-b46e-8366-9700d3604cf1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992438promethazine HCl 12.5 MG Oral TabletPSNda246971-20b8-b46e-8366-9700d3604cf11023
992438promethazine hydrochloride 12.5 MG Oral TabletSCDda246971-20b8-b46e-8366-9700d3604cf11023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1591-06362915910030 TABLET in 1 BOTTLE (63629-1591-0) 30 tablet2015-06-160000-00-00NoNoCurrent
63629-1591-16362915910112 TABLET in 1 BOTTLE (63629-1591-1) 12 tablet2006-03-200000-00-00NoNoCurrent
63629-1591-2636291591024 TABLET in 1 BOTTLE (63629-1591-2) 4 tablet2023-03-030000-00-00NoNoCurrent
63629-1591-3636291591032 TABLET in 1 BOTTLE (63629-1591-3) 2 tablet2024-04-020000-00-00NoNoCurrent
63629-1591-46362915910430 TABLET in 1 BOTTLE (63629-1591-4) 30 tablet2005-12-140000-00-00NoNoCurrent
63629-1591-5636291591056 TABLET in 1 BOTTLE (63629-1591-5) 6 tablet2012-02-210000-00-00NoNoCurrent
63629-1591-66362915910610 TABLET in 1 BOTTLE (63629-1591-6) 10 tablet2009-07-170000-00-00NoNoCurrent
63629-1591-76362915910740 TABLET in 1 BOTTLE (63629-1591-7) 40 tablet2013-03-010000-00-00NoNoCurrent
63629-1591-86362915910820 TABLET in 1 BOTTLE (63629-1591-8) 20 tablet2013-03-210000-00-00NoNoCurrent
63629-1591-96362915910960 TABLET in 1 BOTTLE (63629-1591-9) 60 tablet2014-10-140000-00-00NoNoCurrent