FDA.reportPublic FDA data

Oxycodone/APAP

Product NDC
72189-375
Requested package NDC
72189-375-90
11-digit product format
721890375
Labeler code
72189
Product ID
72189-375_4c4c55ca-eef7-8b39-e063-6294a90adf3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone/APAP
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA201278
Marketing category
ANDA
Marketing start
2022-09-09
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 7.5 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201278-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2014-08-28
A201278-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2014-08-28
A201278-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2014-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A201278-001AA
A201278-002AA
A201278-003AA

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 22:54:322026-06A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28a50c72e98297…
2026-08-01 22:54:322026-06A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28a50c72e98297…
2026-08-01 22:54:322026-06A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201278-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A201278-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A201278-003AA1a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackac6b4a26-7ead-458e-8a3d-591aa07093432026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackef2c1fe2-75dd-43cf-871d-540c5e36d3632026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackfcb09a57-76d8-413c-801b-8d8ea0c3f1db2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack1c793d37-cbc9-4d76-a84a-d076b51011432026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cd2e535-dd11-4bfb-e063-6394a90a9fbc2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4d9e7c39-3e71-48c7-87c7-302db1835f112026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepacke6c47385-638a-41cd-93d9-b7ee205aa0942026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENRhodes Pharmaceuticals LLC5999f3c3-3225-4d24-82cd-0b8d7a3095872026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack639aba0b-1ef6-415f-9732-ebf52bcc1b862026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack79c3af61-19e7-40e5-bd20-2cea52f0bd3a2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone/APAPOXYCODONE/APAPDirect_Rxe84245ca-957f-e85b-e053-2a95a90a836b2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
ndc (package): 72189-375-90
ndc (product): 72189-375
ndc11 (package): 72189037590
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENRedPharm Drug2c6014de-8901-9d83-e063-6294a90ad37b2025-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
PercocetOXYCODONE/APAPDirect_Rxee151649-b52a-0a51-e053-2a95a90a6c352025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPad03068c-1af4-46ce-bdea-c2745b1c1e522022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.3e89f02d-b6e7-4641-82d4-f756518a89142022-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.0dcb491a-54e8-486b-9575-788525a178cf2021-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278

Additional Listing Data#

Finished product
Yes
Brand name base
Oxycodone/APAP
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE325 mg/1
ACETAMINOPHEN7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C1ENJ2TE6CInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049225Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e84245ca-957f-e85b-e053-2a95a90a836bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-375-302025-04-04C16284748780-12cef2736-7492-d83d-e063-dadaa90ab31fOxycodone/APAP
72189-375-602025-04-04C16284748780-12cef2736-7492-d83d-e063-dadaa90ab31fOxycodone/APAP
72189-375-302025-01-30C16284748780-12cef2736-7492-d83d-e063-dadaa90ab31fOxycodone/APAP
72189-375-602025-01-30C16284748780-12cef2736-7492-d83d-e063-dadaa90ab31fOxycodone/APAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-375-30Oxycodone/APAP30 in 1 BOTTLETABLET306
72189-375-60Oxycodone/APAP60 in 1 BOTTLETABLET606
72189-375-72Oxycodone/APAP120 in 1 BOTTLETABLET1206
72189-375-90Oxycodone/APAP90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-375-30EA - Each72189-375caf72ba9-d4d3-4c1d-9c9c-4f53cec7b3f612023-01-09
72189-375-60EA - Each72189-375612fb765-ccef-426c-b4a9-4de96aead2bf12022-10-06
72189-375-90EA - Each72189-375910934df-69f2-49fc-9071-917b034d096512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-375OXYCODONE/APAP TABLET [DIRECT_RX]5Current NDC, Legacy NDC, 4 package rows20250409_e84245ca-957f-e85b-e053-2a95a90a836b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSNe84245ca-957f-e85b-e053-2a95a90a836b6
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCDe84245ca-957f-e85b-e053-2a95a90a836b6
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSYe84245ca-957f-e85b-e053-2a95a90a836b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-375-907218903759090 TABLET in 1 BOTTLE (72189-375-90) 90 tablet2022-09-09NoNoCurrent