FDA.reportPublic FDA data

Promethazine Hydrochloride and Codeine Phosphate

Product NDC
50383-804
11-digit product format
503830804
Labeler code
50383
Product ID
50383-804_6994efab-2353-4868-bcde-c3ee3a2b1e8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Codeine Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA040151
Marketing category
ANDA
Marketing start
1997-08-26
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Active strength
10 mg/5mL; mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product 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
50383-804-042025-12-17C16284748780-11030e365-4165-111a-e063-dadaa90a10e2168951c0-773d-4f3d-9745-cc6de2063b61
50383-804-162025-12-17C16284748780-11030e365-4165-111a-e063-dadaa90a10e2168951c0-773d-4f3d-9745-cc6de2063b61
50383-804-042024-07-30C16284748780-11030e365-4165-111a-e063-dadaa90a10e2168951c0-773d-4f3d-9745-cc6de2063b61
50383-804-162024-07-30C16284748780-11030e365-4165-111a-e063-dadaa90a10e2168951c0-773d-4f3d-9745-cc6de2063b61
50383-804-042024-01-30C16284748780-11030e365-4165-111a-e063-dadaa90a10e2168951c0-773d-4f3d-9745-cc6de2063b61
50383-804-162024-01-30C16284748780-11030e365-4165-111a-e063-dadaa90a10e2168951c0-773d-4f3d-9745-cc6de2063b61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-804-16ML - Milliliter50383-8040214014c-8080-4415-8bc1-e2523bd6594912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]12
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
CODEINEACTIVE MOIETYQ830PW7520PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
CITRIC ACIDINACTIVE INGREDIENT2968PHW8QPPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-804PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION [AKORN]28Legacy NDC20230112_168951c0-773d-4f3d-9745-cc6de2063b61.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 SolutionPSN47d4eb4f-6dd4-44b9-aea1-19c4bfc1d4255
991486codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD47d4eb4f-6dd4-44b9-aea1-19c4bfc1d4255
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral SyrupSY47d4eb4f-6dd4-44b9-aea1-19c4bfc1d4255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-804-0450383080404118 mL in 1 BOTTLE (50383-804-04) 118 ml1997-08-260000-00-00NoNoCurrent
50383-804-1650383080416473 mL in 1 BOTTLE (50383-804-16) 473 ml1997-08-260000-00-00NoNoCurrent