FDA.reportPublic FDA data

Percocet

Product NDC
72189-397
Requested package NDC
72189-397-30
11-digit product format
721890397
Labeler code
72189
Product ID
72189-397_2c4cdf7a-45d9-784b-e063-6294a90a82b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone/APAP
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA201278
Marketing category
ANDA
Marketing start
2022-11-22
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
2027-12-31
Current FDA listing
Yes

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 · 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.

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 UTC2026-02A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-288072bd15b7f6…

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 UTC2026-02A201278-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201278-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201278-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201278-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201278-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201278-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201278-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201278-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201278-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201278-001AA18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Percocet
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
OXYCODONE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee151649-b52a-0a51-e053-2a95a90a6c35Available 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
72189-397-302025-01-30C16284748780-12cef2736-68de-d83d-e063-dadaa90ab31fOxycodone/APAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-397-30Percocet30 in 1 BOTTLETABLET302
72189-397-60Percocet60 in 1 BOTTLETABLET602
72189-397-72Percocet120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-397-30EA - Each72189-3977f8d6e40-0743-4517-b71a-6fcf336323ed12023-01-09
72189-397-60EA - Each72189-397ef482995-0659-4d37-928e-2e0abbcc934012026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-397PERCOCET (OXYCODONE/APAP) TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 3 package rows20221123_ee151649-b52a-0a51-e053-2a95a90a6c35.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 · 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
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
ndc (package): 72189-397-30
ndc (product): 72189-397
ndc11 (package): 72189039730
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-397-307218903973030 TABLET in 1 BOTTLE (72189-397-30) 30 tablet2022-11-220000-00-00NoNoCurrent