Acetaminophen and Codeine Phosphate

Product NDC
45865-466
11-digit product format
458650466
Labeler code
45865
Product ID
45865-466_71c6f45f-af61-0c1e-e053-2a95a90ac402
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA202800
Marketing category
ANDA
Marketing start
2013-04-15
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
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
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-466-30Acetaminophen and Codeine Phosphate30 in 1 BOTTLETABLET301
45865-466-60Acetaminophen and Codeine Phosphate60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-466ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20180725_71c6f45f-af60-0c1e-e053-2a95a90ac402.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN71c6f45f-af60-0c1e-e053-2a95a90ac4021
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD71c6f45f-af60-0c1e-e053-2a95a90ac4021
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY71c6f45f-af60-0c1e-e053-2a95a90ac4021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-466-304586504663030 TABLET in 1 BOTTLE (45865-466-30) 30 tablet2018-01-010000-00-00NoNoCurrent
45865-466-604586504666060 TABLET in 1 BOTTLE (45865-466-60) 60 tablet2018-01-010000-00-00NoNoCurrent