FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
61919-437
Requested package NDC
61919-437-30
11-digit product format
619190437
Labeler code
61919
Product ID
61919-437_94e5102d-9222-52ac-e053-2995a90acf7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE AND ACETAMINOPHE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA201972
Marketing category
ANDA
Marketing start
2018-03-12
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-43761919-437-30DDiscontinued by firm2026-08-03
excluded packagepackage61919-43761919-437-30IInactivated by FDA2026-08-03

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

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
61919-437-302023-01-30C16284748780-1f386c649-b9a1-0266-e053-dadaa90a7c1aOXYCODONE APAP
61919-437-602023-01-30C16284748780-1f386c649-b9a1-0266-e053-dadaa90a7c1aOXYCODONE APAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-437-30OXYCODONE AND ACETAMINOPHEN30 in 1 BOTTLETABLET304
61919-437-60OXYCODONE AND ACETAMINOPHEN60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-437-30EA - Each61919-437ac3686a0-5bb8-41f5-9564-ebe1d83d762b12019-06-19
61919-437-60EA - Each61919-43718ba599d-709d-4c48-9fa6-940a1e9d439612019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-437OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHE) TABLET [DIRECT RX]4Legacy NDC, 2 package rows20191015_67369a20-8ff0-53d0-e053-2991aa0a58f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN67369a20-8ff0-53d0-e053-2991aa0a58f24
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD67369a20-8ff0-53d0-e053-2991aa0a58f24
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY67369a20-8ff0-53d0-e053-2991aa0a58f24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-437-306191904373030 TABLET in 1 BOTTLE (61919-437-30) 30 tablet2018-03-120000-00-00NoNoCurrent