Oxycodone and Acetaminophen

Product NDC
72022-583
11-digit product format
720220583
Labeler code
72022
Product ID
72022-583_18d97a2f-5cfe-8079-d83a-fab6168026f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Halo Pharmaceutical Inc
Application
ANDA207834
Marketing category
ANDA
Marketing start
2020-02-15
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
8 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72022-583IInactivated by FDA2026-08-03
excluded packagepackage72022-58372022-583-01IInactivated by FDA2026-08-03
excluded packagepackage72022-58372022-583-05IInactivated by FDA2026-08-03

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 · 57 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 packagepackage72022-583-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72022-583-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72022-583-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72022-583-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72022-583-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72022-583-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72022-583-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72022-583-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72022-583-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72022-583-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72022-583-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72022-583-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72022-583-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72022-583-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72022-583-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72022-583-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72022-583-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72022-583-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72022-583-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72022-583-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72022-583-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72022-583-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72022-583-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72022-583-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage72022-583-018af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage72022-583-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage72022-583-01834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage72022-583-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage72022-583-011332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage72022-583-051332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage72022-583-01fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage72022-583-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage72022-583-0186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage72022-583-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage72022-583-01bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage72022-583-05bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage72022-583-018dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage72022-583-058dfbde2a14a4…c9ff85d89658…

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
A207834-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORAL2019-08-15
A207834-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORAL2019-08-15
A207834-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORAL2019-08-15

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 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2019-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2019-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2019-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2019-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2019-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2019-08-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2019-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2019-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2019-08-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2019-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2019-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2019-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2019-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2019-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2019-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2019-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2019-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2019-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2019-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2019-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2019-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2019-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2019-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2019-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2019-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2019-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2019-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2019-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2019-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2019-08-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2019-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2019-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2019-08-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2019-08-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2019-08-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2019-08-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2019-08-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207834-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2019-08-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207834-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2019-08-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207834-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2019-08-158072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207834-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207834-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207834-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207834-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207834-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207834-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207834-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207834-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207834-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207834-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207834-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207834-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207834-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207834-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207834-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207834-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207834-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207834-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207834-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207834-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207834-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207834-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207834-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207834-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207834-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207834-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207834-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207834-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207834-002AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207834-003AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207834-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207834-002AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207834-003AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207834-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207834-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207834-003AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207834-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207834-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207834-003AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207834-001AA174a2ff9319b5…

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
72022-583-012021-01-29C16284748780-1ba0f9c33-1452-a910-e053-dadaa90a0b85Package Insert
72022-583-052021-01-29C16284748780-1ba0f9c33-1452-a910-e053-dadaa90a0b85Package Insert

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72022-583-01Oxycodone and Acetaminophen100 in 1 BOTTLETABLET1003
72022-583-05Oxycodone and Acetaminophen500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72022-583OXYCODONE AND ACETAMINOPHEN TABLET [HALO PHARMACEUTICAL INC]3Legacy NDC, 2 package rows20200215_e648ccbd-a8bb-ecfe-1bc9-7b99d33152e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNe648ccbd-a8bb-ecfe-1bc9-7b99d33152e13
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSNe648ccbd-a8bb-ecfe-1bc9-7b99d33152e13
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSNe648ccbd-a8bb-ecfe-1bc9-7b99d33152e13
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDe648ccbd-a8bb-ecfe-1bc9-7b99d33152e13
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCDe648ccbd-a8bb-ecfe-1bc9-7b99d33152e13
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCDe648ccbd-a8bb-ecfe-1bc9-7b99d33152e13
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYe648ccbd-a8bb-ecfe-1bc9-7b99d33152e13
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSYe648ccbd-a8bb-ecfe-1bc9-7b99d33152e13
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSYe648ccbd-a8bb-ecfe-1bc9-7b99d33152e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
72022-583-0172022058301100 in 1 BOTTLEHistorical
72022-583-0572022058305500 in 1 BOTTLEHistorical