Promethazine VC With Codeine

Product NDC
55045-1266
11-digit product format
550451266
Labeler code
55045
Product ID
55045-1266_e3562eaf-3ea6-4b11-903d-43479c7a1f1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA040660
Marketing category
ANDA
Marketing start
2006-12-07
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
DEA schedule
CV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
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2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
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47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product 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
55045-1266-8Promethazine VC With Codeine118 mL in 1 BOTTLESYRUP1181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55045-1266-8ML - Milliliter55045-1266ec7d9ae0-9bbb-4e59-bcc0-046ad794f79112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
CODEINEACTIVE MOIETYQ830PW7520PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3APROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55045-1266PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20111013_5c3c2c1b-ab52-410b-8c94-c125c6adb4d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996757codeine phosphate 10 MG / phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN5c3c2c1b-ab52-410b-8c94-c125c6adb4d21
996757codeine phosphate 2 MG/ML / phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD5c3c2c1b-ab52-410b-8c94-c125c6adb4d21
996757codeine phosphate 10 MG / phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral SolutionSY5c3c2c1b-ab52-410b-8c94-c125c6adb4d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55045-1266-855045126608118 mL in 1 BOTTLE118 mlHistorical