Oxycodone and Acetaminophen

Product NDC
52959-556
11-digit product format
529590556
Labeler code
52959
Product ID
52959-556_4bedcdef-76de-40e6-ad2b-241fbb6fabe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA040105
Marketing category
ANDA
Marketing start
1996-07-30
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-556IInactivated by FDA2026-10-05
excluded packagepackage52959-55652959-556-02IInactivated by FDA2026-10-05
excluded packagepackage52959-55652959-556-30IInactivated by FDA2026-10-05
excluded packagepackage52959-55652959-556-60IInactivated by FDA2026-10-05
excluded packagepackage52959-55652959-556-90IInactivated by FDA2026-10-05

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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-556-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-556-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-556-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-556-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-556-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-556-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-556-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-556-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-556-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-556-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-556-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-556-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-556-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-556-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-556-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-556-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-556-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-556-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-556-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-556-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-556-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-556-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-556-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-556-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-556-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-556-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-556-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-556-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-556-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-556-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-556-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-556-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-556-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-556-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-556-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-556-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-556-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-556-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-556-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-556-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-556-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-556-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-556-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-556-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-556-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-556-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-556-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-556-90557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040105-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORAL1996-07-30

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-3084e616aacf4f…
2026-08-18 06:07:402026-07A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA1996-07-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA1996-07-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA1996-07-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA1996-07-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA1996-07-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA1996-07-303f01610625f2…
2019-09-15 20:21 UTC2019-09A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA1996-07-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA1996-07-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040105-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL1996-07-30f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040105-001AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040105-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040105-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040105-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040105-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040105-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040105-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040105-001AA1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-556-02Oxycodone and Acetaminophen120 in 1 BOTTLE, PLASTICTABLET1202
52959-556-30Oxycodone and Acetaminophen30 in 1 BOTTLE, PLASTICTABLET302
52959-556-60Oxycodone and Acetaminophen60 in 1 BOTTLE, PLASTICTABLET602
52959-556-90Oxycodone and Acetaminophen90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-556-02EA - Each52959-556df08cfbd-ae86-4552-bbbe-654ad98eaa9712012-07-24
52959-556-30EA - Each52959-5564430f5d6-5905-45dc-8a2c-ff08e270c10312012-07-24
52959-556-60EA - Each52959-55637e90abd-af6b-4ae3-b758-c24c95568e0312012-07-24
52959-556-90EA - Each52959-556b4ebb681-9ac8-4b62-9960-91ee61e4a6fc12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-556OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 4 package rows20111230_aa4940e0-9983-4b53-8278-78c5fcaceba5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSNaa4940e0-9983-4b53-8278-78c5fcaceba52
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCDaa4940e0-9983-4b53-8278-78c5fcaceba52
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSYaa4940e0-9983-4b53-8278-78c5fcaceba52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-556-0252959055602120 in 1 BOTTLE, PLASTICHistorical
52959-556-305295905563030 in 1 BOTTLE, PLASTICHistorical
52959-556-605295905566060 in 1 BOTTLE, PLASTICHistorical
52959-556-905295905569090 in 1 BOTTLE, PLASTICHistorical