FDA.reportPublic FDA data

Promethazine with Codeine

Product NDC
60432-606
11-digit product format
604320606
Labeler code
60432
Product ID
60432-606_525b44c5-5457-437e-b7fd-19a9782bc35e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride and codeine phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA088875
Marketing category
ANDA
Marketing start
1984-12-17
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
Active strength
6 mg/5mL; mg/5mL
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
60432-606-162023-01-30C16284748780-1f386c64a-327c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PROMETHAZINE WITH CODEINE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE WITH CODEINE ORAL SOLUTION Initial U.S. Approval:1952

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60432-606-16Promethazine with Codeine473 mL in 1 BOTTLE, PLASTICSOLUTION47312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-606-16ML - Milliliter60432-6065d051b83-0a38-469d-b706-a5fa632b784612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN6PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
Codeine AnhydrousACTIVE MOIETYUX6OWY2V7JPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
SODIUM PROPIONATE ANHYDROUSINACTIVE INGREDIENT391O0PO49RPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-606PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]12Legacy NDC, 1 package rows20200507_eb9ac8c2-ee04-4eed-9b0e-a25d46a7a044.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 SolutionPSNeb9ac8c2-ee04-4eed-9b0e-a25d46a7a04412
991486codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDeb9ac8c2-ee04-4eed-9b0e-a25d46a7a04412
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral SyrupSYeb9ac8c2-ee04-4eed-9b0e-a25d46a7a04412
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNbba2e022-299e-5927-e053-2995a90a35f13
991486codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDbba2e022-299e-5927-e053-2995a90a35f13
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral SyrupSYbba2e022-299e-5927-e053-2995a90a35f13
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNab0d0c01-34e8-4b78-b375-61e921f763de2
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNe1d6f54f-4e87-469f-9a44-11ca3a28cbfc2
991486codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDab0d0c01-34e8-4b78-b375-61e921f763de2
991486codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDe1d6f54f-4e87-469f-9a44-11ca3a28cbfc2
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral SyrupSYab0d0c01-34e8-4b78-b375-61e921f763de2
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral SyrupSYe1d6f54f-4e87-469f-9a44-11ca3a28cbfc2
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN0a0ce6c1-c683-4bfe-8245-6b755eeb2eac1
991486codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD0a0ce6c1-c683-4bfe-8245-6b755eeb2eac1
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral SyrupSY0a0ce6c1-c683-4bfe-8245-6b755eeb2eac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-606-1660432060616473 mL in 1 BOTTLE, PLASTIC (60432-606-16) 473 ml1984-12-170000-00-00NoNoCurrent