ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
71610-111
11-digit product format
716100111
Labeler code
71610
Product ID
71610-111_c998316d-8c03-4d5a-a57c-3d63398d85de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040419
Marketing category
ANDA
Marketing start
2011-07-06
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-111-30EA - Each71610-1119f5d54c7-8938-43ff-8edc-7dafd34606ad12018-10-11
71610-111-45EA - Each71610-1119de93d90-28a4-4d49-9d05-65c486afc6e412018-10-11
71610-111-46EA - Each71610-11188946dec-962e-4622-a7c6-f1d7a4cc809812018-10-11
71610-111-53EA - Each71610-11185700392-b2a7-4b85-b704-e841d802248c12018-10-11
71610-111-54EA - Each71610-111e5a97115-8744-4910-a495-114724e1b71112018-10-11
71610-111-60EA - Each71610-1111266511d-c5b2-42c9-a6c6-1ffa2170561f12018-10-11
71610-111-70EA - Each71610-111f69daa9d-f8bc-4555-bf2b-92dcfacbbd6c12018-10-11
71610-111-72EA - Each71610-111a1cd01ec-d4cc-432f-9120-3a02961e210812018-10-11
71610-111-75EA - Each71610-111ae185c48-bbe7-4ada-9c48-db24eba812d012018-10-11
71610-111-80EA - Each71610-11115e8b1c7-7897-4eef-b404-11c1a57f9b2612018-10-11
71610-111-90EA - Each71610-111585129f4-881a-45e2-9107-b7b070b1e5a312018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-111ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20180828_0b4e335b-afd3-4a87-81de-efb8fa41ae33.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-111-307161001113030 TABLET in 1 BOTTLE (71610-111-30) 30 tablet2018-08-090000-00-00NoNoCurrent
71610-111-457161001114545 TABLET in 1 BOTTLE (71610-111-45) 45 tablet2018-08-090000-00-00NoNoCurrent
71610-111-467161001114656 TABLET in 1 BOTTLE (71610-111-46) 56 tablet2018-08-060000-00-00NoNoCurrent
71610-111-537161001115360 TABLET in 1 BOTTLE (71610-111-53) 60 tablet2018-08-090000-00-00NoNoCurrent
71610-111-547161001115484 TABLET in 1 BOTTLE (71610-111-54) 84 tablet2018-08-060000-00-00NoNoCurrent
71610-111-607161001116090 TABLET in 1 BOTTLE (71610-111-60) 90 tablet2018-08-090000-00-00NoNoCurrent
71610-111-7071610011170120 TABLET in 1 BOTTLE (71610-111-70) 120 tablet2018-08-090000-00-00NoNoCurrent
71610-111-7271610011172112 TABLET in 1 BOTTLE (71610-111-72) 112 tablet2018-08-060000-00-00NoNoCurrent
71610-111-7571610011175150 TABLET in 1 BOTTLE (71610-111-75) 150 tablet2018-08-060000-00-00NoNoCurrent
71610-111-8071610011180180 TABLET in 1 BOTTLE (71610-111-80) 180 tablet2018-08-090000-00-00NoNoCurrent
71610-111-9071610011190240 TABLET in 1 BOTTLE (71610-111-90) 240 tablet2018-08-090000-00-00NoNoCurrent