Promethazine Hydrochloride

Product NDC
63187-338
11-digit product format
631870338
Labeler code
63187
Product ID
63187-338_bf3c6e56-7135-47cf-b2b9-edc9ecc4ea47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA087953
Marketing category
ANDA
Marketing start
1982-11-15
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
6 mg/5mL
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
63187-338-042021-01-29C16284748780-1ba0f9c33-577e-a910-e053-dadaa90a0b85PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-338-04Promethazine Hydrochloride118 mL in 1 BOTTLE, PLASTICSYRUP1182

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-338PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]2Legacy NDC, 1 package rows20190130_c53f033b-212a-4c12-b205-b17241d93d00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNc53f033b-212a-4c12-b205-b17241d93d002
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDc53f033b-212a-4c12-b205-b17241d93d002
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSYc53f033b-212a-4c12-b205-b17241d93d002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63187-338-0463187033804118 mL in 1 BOTTLE, PLASTIC118 mlHistorical