FDA.reportPublic FDA data

Promethazine with Codeine

Product NDC
50090-4127
11-digit product format
500904127
Labeler code
50090
Product ID
50090-4127_d03ec487-5b44-4a19-aede-4cca9e402fee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride and codeine phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
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
2020-12-31
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
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
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
50090-4127-22023-01-30C16284748780-1f386c64a-0713-0266-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
50090-4127-2Promethazine with Codeine473 mL in 1 BOTTLE, PLASTICSOLUTION4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4127PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SOLUTION [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20190216_e1d6f54f-4e87-469f-9a44-11ca3a28cbfc.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 SolutionPSNe1d6f54f-4e87-469f-9a44-11ca3a28cbfc2
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 SyrupSYe1d6f54f-4e87-469f-9a44-11ca3a28cbfc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4127-250090412702473 mL in 1 BOTTLE, PLASTIC (50090-4127-2) 473 ml2019-02-050000-00-00NoNoCurrent