Oxycodone and Acetaminophen

Product NDC
55700-498
11-digit product format
557000498
Labeler code
55700
Product ID
55700-498_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
55700-498-012024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-052024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-102024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-142024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-152024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-202024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-212024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-242024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-282024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-302024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-402024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-562024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-602024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-902024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-012024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-052024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-102024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-142024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-152024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-202024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-212024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-242024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-282024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-302024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-402024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-562024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-602024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b
55700-498-902024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e229a4fffe-8cd1-4af9-aa26-526253901e4b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-498-01EA - Each55700-498a81c0ca7-9c4b-4685-af5d-725237ae5a5f12017-03-06
55700-498-05EA - Each55700-4986f85bbb2-6bd2-4ac6-9539-21471a87a05312020-01-03
55700-498-10EA - Each55700-498b23440ed-edaf-4d5d-a0b2-96539fb304a412019-07-02
55700-498-14EA - Each55700-49865930224-e728-4548-a31a-316f314b8ed012017-05-04
55700-498-15EA - Each55700-4989e30711b-368f-4e1b-ad7d-abdeaff6481312017-03-06
55700-498-20EA - Each55700-4989d9a0df1-3f24-403a-a6c3-1e8b3a8b8e1412017-03-06
55700-498-21EA - Each55700-498058da635-685f-4d59-a12f-f61846ce9a3b12017-05-04
55700-498-24EA - Each55700-498bb421720-89df-443d-8ef7-c9829e07b30712020-08-06
55700-498-30EA - Each55700-49828827b28-0266-4abb-a2b6-1087f475907c12017-03-06
55700-498-40EA - Each55700-4982e0511fc-181e-4596-9256-285e352e0c6e12017-03-06
55700-498-60EA - Each55700-498102cdfb3-a54b-4dbd-bb3a-253a49f7eff912017-03-06
55700-498-90EA - Each55700-498da303743-cd40-4863-a27d-422da9c0c59d12017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-498-0155700049801120 TABLET in 1 BOTTLE (55700-498-01) 120 tablet2017-02-100000-00-00NoNoCurrent
55700-498-05557000498055 TABLET in 1 BOTTLE (55700-498-05) 5 tablet2019-11-200000-00-00NoNoCurrent
55700-498-105570004981010 TABLET in 1 BOTTLE (55700-498-10) 10 tablet2019-06-140000-00-00NoNoCurrent
55700-498-145570004981414 TABLET in 1 BOTTLE (55700-498-14) 14 tablet2017-04-140000-00-00NoNoCurrent
55700-498-155570004981515 TABLET in 1 BOTTLE (55700-498-15) 15 tablet2017-02-100000-00-00NoNoCurrent
55700-498-215570004982121 TABLET in 1 BOTTLE (55700-498-21) 21 tablet2017-04-140000-00-00NoNoCurrent
55700-498-245570004982424 TABLET in 1 BOTTLE (55700-498-24) 24 tablet2020-06-170000-00-00NoNoCurrent
55700-498-285570004982821 TABLET in 1 BOTTLE (55700-498-28) 21 tablet2019-11-080000-00-00NoNoCurrent
55700-498-305570004983030 TABLET in 1 BOTTLE (55700-498-30) 30 tablet2017-02-100000-00-00NoNoCurrent
55700-498-405570004984040 TABLET in 1 BOTTLE (55700-498-40) 40 tablet2017-02-100000-00-00NoNoCurrent
55700-498-565570004985656 TABLET in 1 BOTTLE (55700-498-56) 56 tablet2018-08-100000-00-00NoNoCurrent
55700-498-605570004986060 TABLET in 1 BOTTLE (55700-498-60) 60 tablet2017-02-100000-00-00NoNoCurrent
55700-498-905570004989090 TABLET in 1 BOTTLE (55700-498-90) 90 tablet2017-02-100000-00-00NoNoCurrent