FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
71335-1959
Requested package NDC
71335-1959-3
11-digit product format
713351959
Labeler code
71335
Product ID
71335-1959_6eeeb7dc-4dfc-4cb4-99cf-ffcee9112f00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207419
Marketing category
ANDA
Marketing start
2017-04-11
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
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 · 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
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
88d05136-7b04-4b25-af1c-6bc72fdbcbd7Available 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
71335-1959-1OXYCODONE AND ACETAMINOPHEN21 in 1 BOTTLETABLET21103
71335-1959-2OXYCODONE AND ACETAMINOPHEN36 in 1 BOTTLETABLET36103
71335-1959-3OXYCODONE AND ACETAMINOPHEN20 in 1 BOTTLETABLET20103
71335-1959-4OXYCODONE AND ACETAMINOPHEN30 in 1 BOTTLETABLET30103
71335-1959-5OXYCODONE AND ACETAMINOPHEN45 in 1 BOTTLETABLET45103
71335-1959-6OXYCODONE AND ACETAMINOPHEN60 in 1 BOTTLETABLET60103
71335-1959-7OXYCODONE AND ACETAMINOPHEN90 in 1 BOTTLETABLET90103
71335-1959-8OXYCODONE AND ACETAMINOPHEN120 in 1 BOTTLETABLET120103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1959-2EA - Each71335-195923517ca5-c0aa-4cea-a1a8-f3fb9082bf0c12021-12-08
71335-1959-4EA - Each71335-1959e9c322d1-1a5c-4aef-b4fd-549e66baf1bb12021-12-08
71335-1959-6EA - Each71335-19598426b768-d736-4cd9-9798-4651e47212fb12021-12-08
71335-1959-7EA - Each71335-1959ed72f5f5-bce5-4b94-afb5-78a6d18dca7912021-12-08
71335-1959-8EA - Each71335-19595b4d2794-4f25-4f28-86bf-97455aa7064812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1959OXYCODONE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 8 package rows20240602_88d05136-7b04-4b25-af1c-6bc72fdbcbd7.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
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
ndc (package): 71335-1959-3
ndc (product): 71335-1959
ndc11 (package): 71335195903
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
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSN88d05136-7b04-4b25-af1c-6bc72fdbcbd7103
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD88d05136-7b04-4b25-af1c-6bc72fdbcbd7103
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSY88d05136-7b04-4b25-af1c-6bc72fdbcbd7103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1959-37133519590320 TABLET in 1 BOTTLE (71335-1959-3) 20 tablet2024-05-310000-00-00NoNoCurrent