Promethazine Hydrochloride

Product NDC
68788-9270
11-digit product format
687889270
Labeler code
68788
Product ID
68788-9270_27e3fdde-509b-4f8b-95ec-35e6e508bb67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA091179
Marketing category
ANDA
Marketing start
2014-01-02
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9270-1Promethazine Hydrochloride10 in 1 BOTTLETABLET105
68788-9270-2Promethazine Hydrochloride20 in 1 BOTTLETABLET205
68788-9270-3Promethazine Hydrochloride30 in 1 BOTTLETABLET305
68788-9270-5Promethazine Hydrochloride15 in 1 BOTTLETABLET155
68788-9270-6Promethazine Hydrochloride60 in 1 BOTTLETABLET605
68788-9270-8Promethazine Hydrochloride12 in 1 BOTTLETABLET125
68788-9270-9Promethazine Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9270PROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]5Legacy NDC, 7 package rows20200827_01377b4c-e5be-41b7-877f-3102b40bda91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN01377b4c-e5be-41b7-877f-3102b40bda915
992447promethazine hydrochloride 25 MG Oral TabletSCD01377b4c-e5be-41b7-877f-3102b40bda915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9270-16878892700110 TABLET in 1 BOTTLE (68788-9270-1) 10 tablet2014-01-020000-00-00NoNoCurrent
68788-9270-26878892700220 TABLET in 1 BOTTLE (68788-9270-2) 20 tablet2014-01-020000-00-00NoNoCurrent
68788-9270-36878892700330 TABLET in 1 BOTTLE (68788-9270-3) 30 tablet2014-01-020000-00-00NoNoCurrent
68788-9270-56878892700515 TABLET in 1 BOTTLE (68788-9270-5) 15 tablet2014-01-020000-00-00NoNoCurrent
68788-9270-66878892700660 TABLET in 1 BOTTLE (68788-9270-6) 60 tablet2014-01-020000-00-00NoNoCurrent
68788-9270-86878892700812 TABLET in 1 BOTTLE (68788-9270-8) 12 tablet2014-01-020000-00-00NoNoCurrent
68788-9270-96878892700990 TABLET in 1 BOTTLE (68788-9270-9) 90 tablet2014-01-020000-00-00NoNoCurrent