Xolox

Product NDC
21695-924
11-digit product format
216950924
Labeler code
21695
Product ID
21695-924_35b99e65-32d3-43bc-89d9-2e7c7838aa14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone HCl and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA040676
Marketing category
ANDA
Marketing start
2009-03-01
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
10 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-924IInactivated by FDA2026-08-17
excluded packagepackage21695-92421695-924-40IInactivated by FDA2026-08-17

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 · 44 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 packagepackage21695-924-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-924-40f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-924-402ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-924-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-924-40cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-924-40cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-924-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-924-40ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-924-400efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-924-40ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-924-40367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-924-40557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-924-408af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-924-40834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-924-401332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-924-40fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-924-4086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-924-40bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-924-408dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-924-40e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-924-409bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-924-40110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040676-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE500MG;10MGTABLET / ORAL2006-04-19

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-193f01610625f2…
2019-09-15 20:21 UTC2019-09A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040676-001OXYCODONE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL2006-04-19e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-924-402019-09-24C16284748780-1934fe258-4c92-48b1-e053-8cdaa90a720aXolox

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-924-40Xolox40 in 1 BOTTLETABLET401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-924-40EA - Each21695-9241206b49c-ef5e-4929-9114-15877957a71112012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-924XOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110422_35b99e65-32d3-43bc-89d9-2e7c7838aa14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049651oxyCODONE HCl 10 MG / acetaminophen 500 MG Oral TabletPSN35b99e65-32d3-43bc-89d9-2e7c7838aa141
1049655Xolox 10 MG / 500 MG Oral TabletPSN35b99e65-32d3-43bc-89d9-2e7c7838aa141
1049655acetaminophen 500 MG / oxycodone hydrochloride 10 MG Oral Tablet [Xolox]SBD35b99e65-32d3-43bc-89d9-2e7c7838aa141
1049651acetaminophen 500 MG / oxycodone hydrochloride 10 MG Oral TabletSCD35b99e65-32d3-43bc-89d9-2e7c7838aa141
1049651APAP 500 MG / oxycodone hydrochloride 10 MG Oral TabletSY35b99e65-32d3-43bc-89d9-2e7c7838aa141
1049655APAP 500 MG / Oxycodone Hydrochloride 10 MG Oral Tablet [Xolox]SY35b99e65-32d3-43bc-89d9-2e7c7838aa141
1049655Xolox (APAP 500 MG / oxycodone hydrochloride 10 MG) Oral TabletSY35b99e65-32d3-43bc-89d9-2e7c7838aa141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-924-402169509244040 in 1 BOTTLEHistorical