FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
71335-2049
11-digit product format
713352049
Labeler code
71335
Product ID
71335-2049_0528bfb6-38fa-448e-a709-859515405822
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207510
Marketing category
ANDA
Marketing start
2019-06-01
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 10 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
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
A207510-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2018-03-21
A207510-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2018-03-21
A207510-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2018-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207510-001AA
A207510-002AA
A207510-003AA

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207510-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207510-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207510-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207510-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207510-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207510-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207510-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207510-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207510-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207510-001AA18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
OXYCODONE AND ACETAMINOPHEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE325 mg/1
ACETAMINOPHEN10 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
1049214Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
71b1a9be-3231-4b09-a195-d5893104bd4aAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2049-1OXYCODONE AND ACETAMINOPHEN30 in 1 BOTTLETABLET30102
71335-2049-2OXYCODONE AND ACETAMINOPHEN120 in 1 BOTTLETABLET120102
71335-2049-3OXYCODONE AND ACETAMINOPHEN90 in 1 BOTTLETABLET90102
71335-2049-4OXYCODONE AND ACETAMINOPHEN28 in 1 BOTTLETABLET28102
71335-2049-5OXYCODONE AND ACETAMINOPHEN60 in 1 BOTTLETABLET60102
71335-2049-6OXYCODONE AND ACETAMINOPHEN20 in 1 BOTTLETABLET20102
71335-2049-7OXYCODONE AND ACETAMINOPHEN45 in 1 BOTTLETABLET45102
71335-2049-8OXYCODONE AND ACETAMINOPHEN75 in 1 BOTTLETABLET75102
71335-2049-9OXYCODONE AND ACETAMINOPHEN100 in 1 BOTTLETABLET100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2049OXYCODONE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 9 package rows20240525_71b1a9be-3231-4b09-a195-d5893104bd4a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENMajor Pharmaceuticals1d52272f-a607-4002-a61c-341964522b822026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack25c03c47-0057-41b6-a530-c6ea85eb750f2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENEywa Pharma Inc1da85ac1-46a2-4081-b533-4890ec9e04822026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3339d3bd-b416-4c5b-8984-0c376544d8a92026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.e0d06ec7-9846-4e04-8660-5fd6b2b8e4232025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAmerican Health Packaging79bb61d7-8836-4ce7-91bc-9463efbad9cf2025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXa8206207-ad09-83df-e053-2995a90a78b72025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack71b1a9be-3231-4b09-a195-d5893104bd4a2024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
ndc (product): 71335-2049

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN71b1a9be-3231-4b09-a195-d5893104bd4a102
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD71b1a9be-3231-4b09-a195-d5893104bd4a102
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY71b1a9be-3231-4b09-a195-d5893104bd4a102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2049-17133520490130 TABLET in 1 BOTTLE (71335-2049-1) 30 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-271335204902120 TABLET in 1 BOTTLE (71335-2049-2) 120 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-37133520490390 TABLET in 1 BOTTLE (71335-2049-3) 90 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-47133520490428 TABLET in 1 BOTTLE (71335-2049-4) 28 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-57133520490560 TABLET in 1 BOTTLE (71335-2049-5) 60 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-67133520490620 TABLET in 1 BOTTLE (71335-2049-6) 20 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-77133520490745 TABLET in 1 BOTTLE (71335-2049-7) 45 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-87133520490875 TABLET in 1 BOTTLE (71335-2049-8) 75 tablet2022-02-280000-00-00NoNoCurrent
71335-2049-971335204909100 TABLET in 1 BOTTLE (71335-2049-9) 100 tablet2022-02-280000-00-00NoNoCurrent