Promethazine with Codeine

Product NDC
17856-1585
11-digit product format
178561585
Labeler code
17856
Product ID
17856-1585_482db043-19a2-486d-9dee-63a1fe4d49fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Codeine Phosphate
Dosage form
SYRUP
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA040650
Marketing category
ANDA
Marketing start
2006-01-31
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
Active strength
6 mg/5mL; mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [CS]
DEA schedule
CV
NDC exclude flag
E
Listing certified through
2018-12-31
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
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-1585-52020-01-31C16284748780-19d75b9d0-d333-f424-e053-dadaa90a57cePROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1585-5Promethazine with Codeine5 mL in 1 CUPSYRUP52

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3APROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1585PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 1 package rows20140328_4e0d550e-6281-48ce-819f-ca37fcca53e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN4e0d550e-6281-48ce-819f-ca37fcca53e02
991486codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD4e0d550e-6281-48ce-819f-ca37fcca53e02
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral SyrupSY4e0d550e-6281-48ce-819f-ca37fcca53e02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-1585-5178561585055 mL in 1 CUP5 mlHistorical