Oxycodone and Acetaminophen

Product NDC
55700-496
11-digit product format
557000496
Labeler code
55700
Product ID
55700-496_8c9196fe-65e3-4e1f-b71b-ae9e08d5a4e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA201972
Marketing category
ANDA
Marketing start
2016-12-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-496-012024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-142024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-152024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-212024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-302024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-602024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-902024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-012024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-142024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-152024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-212024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-302024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-602024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-496-902024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-496-01EA - Each55700-49643fd56e2-3e1a-4852-aa3a-4dd13532804512017-03-06
55700-496-14EA - Each55700-4965ae4543a-1243-4d7f-b79f-b79dd6bb6f3212017-05-04
55700-496-15EA - Each55700-49627b0d693-1ad5-42d3-8bbe-b428eb708f1612019-05-02
55700-496-21EA - Each55700-4961c568fde-8ca2-4612-b986-bc6dbd8c852d12017-05-04
55700-496-30EA - Each55700-49663b7867e-1d0c-4b5f-93e2-d72ad5b4286112017-03-06
55700-496-60EA - Each55700-496837d0e7e-58dc-4f40-89e3-c6d8f35e73b812017-03-06
55700-496-90EA - Each55700-496accd9565-3c85-4d4e-9b4b-a346c540545212017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-496-0155700049601120 TABLET in 1 BOTTLE (55700-496-01) 120 tablet2017-02-100000-00-00NoNoCurrent
55700-496-145570004961414 TABLET in 1 BOTTLE (55700-496-14) 14 tablet2017-04-140000-00-00NoNoCurrent
55700-496-155570004961515 TABLET in 1 BOTTLE (55700-496-15) 15 tablet2019-04-110000-00-00NoNoCurrent
55700-496-215570004962121 TABLET in 1 BOTTLE (55700-496-21) 21 tablet2017-04-140000-00-00NoNoCurrent
55700-496-305570004963030 TABLET in 1 BOTTLE (55700-496-30) 30 tablet2017-02-100000-00-00NoNoCurrent
55700-496-605570004966060 TABLET in 1 BOTTLE (55700-496-60) 60 tablet2017-02-100000-00-00NoNoCurrent
55700-496-905570004969090 TABLET in 1 BOTTLE (55700-496-90) 90 tablet2017-02-100000-00-00NoNoCurrent