FDA.reportPublic FDA data

Promethazine VC

Product NDC
0603-1587
11-digit product format
006031587
Labeler code
0603
Product ID
0603-1587_ed359a65-f780-42a8-abd4-ac4287d47968
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine hydrochloride and phenylephrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA040654
Marketing category
ANDA
Marketing start
2006-12-07
Marketing end
2019-10-31
Substance
PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
6 mg/5mL; mg/5mL
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-1587-54ML - Milliliter0603-1587589527cd-4ff7-4478-bd54-a2af9d37cf6012012-07-24
0603-1587-58ML - Milliliter0603-1587f940d560-0255-4ebc-998a-370795248b4012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
MENTHOLINACTIVE INGREDIENTL7T10EIP3APROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE VC (PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
CITRIC ACIDINACTIVE INGREDIENT2968PHW8QPPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3APROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248057phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN1b628a38-3557-4fa4-9e08-4c7de40f9d824
1248057phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD1b628a38-3557-4fa4-9e08-4c7de40f9d824
1248057phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral SolutionSY1b628a38-3557-4fa4-9e08-4c7de40f9d824
1248057phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNb00b296d-6c34-48c8-9cfb-71ccc5c9a9081
1248057phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDb00b296d-6c34-48c8-9cfb-71ccc5c9a9081
1248057phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral SolutionSYb00b296d-6c34-48c8-9cfb-71ccc5c9a9081