FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
55700-496
Requested package NDC
55700-496-01
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55700-49655700-496-01DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201972-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;2.5MGTABLET / ORALAA2013-07-15
A201972-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2013-07-15
A201972-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2013-07-15
A201972-004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2013-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A201972-001AA
A201972-002AA
A201972-003AA
A201972-004AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15a50c72e98297…
2026-08-01 22:54:322026-06A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15a50c72e98297…
2026-08-01 22:54:322026-06A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15a50c72e98297…
2026-08-01 22:54:322026-06A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201972-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A201972-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A201972-003AA1a50c72e98297…
2026-08-01 22:54:322026-06A201972-004AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAurolife Pharma, LLC69df20d9-b1d5-47dc-9ff0-29987284f8c72025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackc12c26be-ba05-4d25-a2bf-f87623c6ae572024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPdd4dbe5b-8d07-4a96-a78d-2f20da761dad2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPdf97ea5a-51df-453b-b1b4-edc74c718ee72019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-496-012024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-142024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-152024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-212024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-302024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-602024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-902024-03-14C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-012024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-142024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-152024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-212024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-302024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-602024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII
55700-496-902024-01-30C16284748780-11030e365-4872-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII

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