FDA.reportPublic FDA data

Acetaminophen and Codeine

Product NDC
43353-010
11-digit product format
433530010
Labeler code
43353
Product ID
43353-010_f872b491-759b-45ca-bdd6-58d15b258184
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040779
Marketing category
ANDA
Marketing start
2008-05-29
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
43353-010-402023-01-30C16284748780-1f386c649-f0c9-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets, USP 300mg/30mg
43353-010-452023-01-30C16284748780-1f386c649-f0c9-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets, USP 300mg/30mg
43353-010-502023-01-30C16284748780-1f386c649-f0c9-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets, USP 300mg/30mg
43353-010-602023-01-30C16284748780-1f386c649-f0c9-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets, USP 300mg/30mg
43353-010-702023-01-30C16284748780-1f386c649-f0c9-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets, USP 300mg/30mg
43353-010-752023-01-30C16284748780-1f386c649-f0c9-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets, USP 300mg/30mg
43353-010-902023-01-30C16284748780-1f386c649-f0c9-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets, USP 300mg/30mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-010-40Acetaminophen and Codeine40 in 1 BOTTLETABLET403
43353-010-45Acetaminophen and Codeine45 in 1 BOTTLETABLET453
43353-010-50Acetaminophen and Codeine50 in 1 BOTTLETABLET503
43353-010-60Acetaminophen and Codeine90 in 1 BOTTLETABLET903
43353-010-70Acetaminophen and Codeine120 in 1 BOTTLETABLET1203
43353-010-75Acetaminophen and Codeine150 in 1 BOTTLETABLET1503
43353-010-90Acetaminophen and Codeine240 in 1 BOTTLETABLET2403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-010-45EA - Each43353-0105f77cd6d-db38-40b5-9578-9f763d805f7d12016-07-19
43353-010-50EA - Each43353-0103d7a504b-e8b0-46eb-b349-58365f216ebb12016-07-19
43353-010-60EA - Each43353-01075b65ac7-0cb3-4c2a-8c82-a9441ce9893112016-07-19
43353-010-70EA - Each43353-010dc88f59c-f020-459b-8354-68e890ece62112016-07-19
43353-010-75EA - Each43353-01011447252-25e4-4a93-bfdf-54ad1dcdde8912016-07-19
43353-010-90EA - Each43353-010250184bb-1365-44b8-9f26-66e7385e1db712016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-010ACETAMINOPHEN AND CODEINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 7 package rows20191219_b84d3e24-693d-4667-ae35-0583b6368610.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNb84d3e24-693d-4667-ae35-0583b63686103
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDb84d3e24-693d-4667-ae35-0583b63686103
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYb84d3e24-693d-4667-ae35-0583b63686103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-010-404335300104040 TABLET in 1 BOTTLE (43353-010-40) 40 tablet2015-04-060000-00-00NoNoCurrent
43353-010-454335300104545 TABLET in 1 BOTTLE (43353-010-45) 45 tablet2015-03-240000-00-00NoNoCurrent
43353-010-504335300105050 TABLET in 1 BOTTLE (43353-010-50) 50 tablet2015-03-240000-00-00NoNoCurrent
43353-010-604335300106090 TABLET in 1 BOTTLE (43353-010-60) 90 tablet2015-03-240000-00-00NoNoCurrent
43353-010-7043353001070120 TABLET in 1 BOTTLE (43353-010-70) 120 tablet2015-03-240000-00-00NoNoCurrent
43353-010-7543353001075150 TABLET in 1 BOTTLE (43353-010-75) 150 tablet2015-03-240000-00-00NoNoCurrent
43353-010-9043353001090240 TABLET in 1 BOTTLE (43353-010-90) 240 tablet2015-03-240000-00-00NoNoCurrent