FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
71335-0701
11-digit product format
713350701
Labeler code
71335
Product ID
71335-0701_b3eeebc3-05cf-4e86-bdef-5d721e79d1fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA088629
Marketing category
ANDA
Marketing start
1990-09-30
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
2023-12-31
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
71335-0701-02024-01-30C16284748780-11030e365-665a-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
71335-0701-12024-01-30C16284748780-11030e365-665a-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
71335-0701-22024-01-30C16284748780-11030e365-665a-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
71335-0701-32024-01-30C16284748780-11030e365-665a-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
71335-0701-42024-01-30C16284748780-11030e365-665a-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
71335-0701-52024-01-30C16284748780-11030e365-665a-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
71335-0701-62024-01-30C16284748780-11030e365-665a-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
71335-0701-72024-01-30C16284748780-11030e365-665a-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
71335-0701-82024-01-30C16284748780-11030e365-665a-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
71335-0701-92024-01-30C16284748780-11030e365-665a-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0701-0Acetaminophen and Codeine Phosphate100 in 1 BOTTLETABLET1004
71335-0701-1Acetaminophen and Codeine Phosphate30 in 1 BOTTLETABLET304
71335-0701-2Acetaminophen and Codeine Phosphate120 in 1 BOTTLETABLET1204
71335-0701-3Acetaminophen and Codeine Phosphate60 in 1 BOTTLETABLET604
71335-0701-4Acetaminophen and Codeine Phosphate90 in 1 BOTTLETABLET904
71335-0701-5Acetaminophen and Codeine Phosphate40 in 1 BOTTLETABLET404
71335-0701-6Acetaminophen and Codeine Phosphate20 in 1 BOTTLETABLET204
71335-0701-7Acetaminophen and Codeine Phosphate112 in 1 BOTTLETABLET1124
71335-0701-8Acetaminophen and Codeine Phosphate84 in 1 BOTTLETABLET844
71335-0701-9Acetaminophen and Codeine Phosphate15 in 1 BOTTLETABLET154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0701-3EA - Each71335-0701feef7df3-da34-4eed-9444-eb099b155bc512018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0701ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]4Legacy NDC, 10 package rows20220129_b3eeebc3-05cf-4e86-bdef-5d721e79d1fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSNb3eeebc3-05cf-4e86-bdef-5d721e79d1fe4
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCDb3eeebc3-05cf-4e86-bdef-5d721e79d1fe4
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSYb3eeebc3-05cf-4e86-bdef-5d721e79d1fe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0701-071335070100100 TABLET in 1 BOTTLE (71335-0701-0) 100 tablet2021-12-270000-00-00NoNoCurrent
71335-0701-17133507010130 TABLET in 1 BOTTLE (71335-0701-1) 30 tablet2010-04-280000-00-00NoNoCurrent
71335-0701-271335070102120 TABLET in 1 BOTTLE (71335-0701-2) 120 tablet2010-04-280000-00-00NoNoCurrent
71335-0701-37133507010360 TABLET in 1 BOTTLE (71335-0701-3) 60 tablet2010-04-280000-00-00NoNoCurrent
71335-0701-47133507010490 TABLET in 1 BOTTLE (71335-0701-4) 90 tablet2010-04-280000-00-00NoNoCurrent
71335-0701-57133507010540 TABLET in 1 BOTTLE (71335-0701-5) 40 tablet2010-04-280000-00-00NoNoCurrent
71335-0701-67133507010620 TABLET in 1 BOTTLE (71335-0701-6) 20 tablet2010-04-280000-00-00NoNoCurrent
71335-0701-771335070107112 TABLET in 1 BOTTLE (71335-0701-7) 112 tablet2010-04-280000-00-00NoNoCurrent
71335-0701-87133507010884 TABLET in 1 BOTTLE (71335-0701-8) 84 tablet2010-04-280000-00-00NoNoCurrent
71335-0701-97133507010915 TABLET in 1 BOTTLE (71335-0701-9) 15 tablet2010-04-280000-00-00NoNoCurrent