FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
67046-903
11-digit product format
670460903
Labeler code
67046
Product ID
67046-903_5a45c22c-dd1d-5bd3-e053-2991aa0aaf92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA088628
Marketing category
ANDA
Marketing start
2017-09-28
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-903-072022-01-28C16284748780-1d6a99b39-67f7-a426-e053-dadaa90af4c2903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-142022-01-28C16284748780-1d6a99b39-67f7-a426-e053-dadaa90af4c2903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-152022-01-28C16284748780-1d6a99b39-67f7-a426-e053-dadaa90af4c2903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-202022-01-28C16284748780-1d6a99b39-67f7-a426-e053-dadaa90af4c2903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-212022-01-28C16284748780-1d6a99b39-67f7-a426-e053-dadaa90af4c2903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-282022-01-28C16284748780-1d6a99b39-67f7-a426-e053-dadaa90af4c2903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-302022-01-28C16284748780-1d6a99b39-67f7-a426-e053-dadaa90af4c2903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-602022-01-28C16284748780-1d6a99b39-67f7-a426-e053-dadaa90af4c2903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-903-07Acetaminophen and Codeine Phosphate7 in 1 BLISTER PACKTABLET71
67046-903-14Acetaminophen and Codeine Phosphate14 in 1 BLISTER PACKTABLET141
67046-903-15Acetaminophen and Codeine Phosphate15 in 1 BLISTER PACKTABLET151
67046-903-20Acetaminophen and Codeine Phosphate20 in 1 BLISTER PACKTABLET201
67046-903-21Acetaminophen and Codeine Phosphate21 in 1 BLISTER PACKTABLET211
67046-903-28Acetaminophen and Codeine Phosphate28 in 1 BLISTER PACKTABLET281
67046-903-30Acetaminophen and Codeine Phosphate30 in 1 BLISTER PACKTABLET301
67046-903-60Acetaminophen and Codeine Phosphate60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-903ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170929_5a45c22c-dd1c-5bd3-e053-2991aa0aaf92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN5a45c22c-dd1c-5bd3-e053-2991aa0aaf921
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD5a45c22c-dd1c-5bd3-e053-2991aa0aaf921
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY5a45c22c-dd1c-5bd3-e053-2991aa0aaf921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-903-07670460903077 TABLET in 1 BLISTER PACK (67046-903-07) 7 tablet2017-09-280000-00-00NoNoCurrent
67046-903-146704609031414 TABLET in 1 BLISTER PACK (67046-903-14) 14 tablet2017-09-280000-00-00NoNoCurrent
67046-903-156704609031515 TABLET in 1 BLISTER PACK (67046-903-15) 15 tablet2017-09-280000-00-00NoNoCurrent
67046-903-206704609032020 TABLET in 1 BLISTER PACK (67046-903-20) 20 tablet2017-09-280000-00-00NoNoCurrent
67046-903-216704609032121 TABLET in 1 BLISTER PACK (67046-903-21) 21 tablet2017-09-280000-00-00NoNoCurrent
67046-903-286704609032828 TABLET in 1 BLISTER PACK (67046-903-28) 28 tablet2017-09-280000-00-00NoNoCurrent
67046-903-306704609033030 TABLET in 1 BLISTER PACK (67046-903-30) 30 tablet2017-09-280000-00-00NoNoCurrent
67046-903-606704609036060 TABLET in 1 BLISTER PACK (67046-903-60) 60 tablet2017-09-280000-00-00NoNoCurrent