FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
61919-871
Requested package NDC
61919-871-90
11-digit product format
619190871
Labeler code
61919
Product ID
61919-871_3a85db26-4c30-c5dc-e063-6294a90ac2a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA207419
Marketing category
ANDA
Marketing start
2019-08-21
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-87161919-871-90IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A207419-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;2.5MGTABLET / ORALAA2017-03-22
A207419-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2017-03-22
A207419-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2017-03-22
A207419-004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2017-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207419-001AA
A207419-002AA
A207419-003AA
A207419-004AA

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-22d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207419-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207419-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-004AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207419-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207419-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207419-003AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207419-004AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207419-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207419-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207419-003AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207419-004AA1d06236e962d9…

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
90a11364-fc42-e94e-e053-2a95a90a9782Available 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, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
61919-871-602025-05-082cef2736-6e83-d83d-e063-dadaa90ab31fOXYCODONE AND ACETAMINOPHEN
61919-871-302025-01-302cef2736-b0b4-d83d-e063-dadaa90ab31fOXYCODONE AND ACETAMINOPHEN
61919-871-602025-01-302cef2736-6e83-d83d-e063-dadaa90ab31fOXYCODONE AND ACETAMINOPHEN
61919-871-902025-01-302cef2736-6eba-d83d-e063-dadaa90ab31fOXYCODONE AND ACETAMINOPHEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-871-60OXYCODONE AND ACETAMINOPHEN60 in 1 BOTTLETABLET606
61919-871-72OXYCODONE AND ACETAMINOPHEN120 in 1 BOTTLETABLET1206
61919-871-30OXYCODONE AND ACETAMINOPHEN30 in 1 BOTTLETABLET302
61919-871-90OXYCODONE AND ACETAMINOPHEN90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-871-30EA - Each61919-87139be9529-b5ee-40c3-8806-fd8686f1321e12019-09-05
61919-871-60EA - Each61919-871cb0850f6-bf99-4a95-adae-894438dfb9b112019-09-05
61919-871-72EA - Each61919-871667e98f2-a5dd-4bab-ac23-6b62fc05b8e912025-08-11
61919-871-90EA - Each61919-871f4250700-c8da-408a-ab53-ecd4d71c8fd412019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-871OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT_RX]3Current NDC, Legacy NDC, 2 package rows20250509_90a11364-fc42-e94e-e053-2a95a90a9782.zip
61919-871OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20230113_90a0f138-3afa-1fb6-e053-2995a90a96fe.zip
61919-871OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20230113_90a0ede7-6c30-1b33-e053-2995a90a2cf8.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENCamber Pharmaceuticals, Inc.42777191-0454-4ccb-8fc3-8b18b0ee43f72025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_Rx90a11364-fc42-e94e-e053-2a95a90a97822025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
ndc (product): 61919-871
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.71c7a627-6ed9-4f49-8cdc-b3228c021e642025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENDirect_Rxe4e27022-581e-ba8c-e053-2a95a90a1ae42025-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.9e4024f4-0f60-dfef-e053-2995a90ac3662024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.925f9787-3d1c-0189-e053-2a95a90a29722024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4a873428-bb5a-4e48-9185-2a27f289110d2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack88d05136-7b04-4b25-af1c-6bc72fdbcbd72024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack96173ce4-4836-43ae-9797-5246f830643a2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3791abd3-fcdf-4c8d-b46d-db6e5c8057702024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack0c85d1b8-ea42-421d-a305-4d338b47150f2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4da8a7bd-0d2e-452c-afb5-fed4e230a9bd2024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.7f3c6dd7-6bc8-450e-aded-997f9cf63a8f2024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP78933d4a-d78a-43bc-9052-a032901ee0502022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP5df7c033-0f31-45bc-8c34-3da45635e66d2022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP484a4323-0758-439d-844f-f04d7e5ef6f32022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENCamber Pharmaceuticals, Inc.2a49ee34-6f1d-4ed3-8daa-343723d2a2be2018-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN90a11364-fc42-e94e-e053-2a95a90a97826
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD90a11364-fc42-e94e-e053-2a95a90a97826
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY90a11364-fc42-e94e-e053-2a95a90a97826
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN90a0ede7-6c30-1b33-e053-2995a90a2cf82
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN90a0f138-3afa-1fb6-e053-2995a90a96fe2
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD90a0ede7-6c30-1b33-e053-2995a90a2cf82
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD90a0f138-3afa-1fb6-e053-2995a90a96fe2
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY90a0ede7-6c30-1b33-e053-2995a90a2cf82
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY90a0f138-3afa-1fb6-e053-2995a90a96fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-871-906191908719090 TABLET in 1 BOTTLE (61919-871-90) 90 tablet2019-08-210000-00-00NoNoCurrent