FDA.reportPublic FDA data

ENDOCET

Product NDC
63629-2189
11-digit product format
636292189
Labeler code
63629
Product ID
63629-2189_9bc5874c-7b6b-43a1-9433-a0746dd1e27e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040330
Marketing category
ANDA
Marketing start
2000-05-26
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 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

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 productproduct63629-2189DDiscontinued by firm2026-08-17
excluded packagepackage63629-218963629-2189-1DDiscontinued by firm2026-08-17

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

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
A040330-001PERCOCETACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;2.5MGTABLET / ORALAARS1999-06-25
A040330-002PERCOCETACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAARS1999-06-25
A040330-003PERCOCETACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAARS2001-11-23
A040330-004PERCOCETACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAARS2001-11-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A040330-001AA
A040330-002AA
A040330-003AA
A040330-004AA

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040330-001PERCOCET325MG;2.5MGTABLET / ORALAARS1999-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07A040330-002PERCOCET325MG;5MGTABLET / ORALAARS1999-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07A040330-003PERCOCET325MG;7.5MGTABLET / ORALAARS2001-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A040330-004PERCOCET325MG;10MGTABLET / ORALAARS2001-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040330-001PERCOCET325MG;2.5MGTABLET / ORALAARS1999-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040330-002PERCOCET325MG;5MGTABLET / ORALAARS1999-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040330-003PERCOCET325MG;7.5MGTABLET / ORALAARS2001-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040330-004PERCOCET325MG;10MGTABLET / ORALAARS2001-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040330-001PERCOCET325MG;2.5MGTABLET / ORALAARS1999-06-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040330-002PERCOCET325MG;5MGTABLET / ORALAARS1999-06-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040330-003PERCOCET325MG;7.5MGTABLET / ORALAARS2001-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040330-004PERCOCET325MG;10MGTABLET / ORALAARS2001-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040330-001PERCOCET325MG;2.5MGTABLET / ORALAARS1999-06-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040330-002PERCOCET325MG;5MGTABLET / ORALAARS1999-06-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040330-003PERCOCET325MG;7.5MGTABLET / ORALAARS2001-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040330-004PERCOCET325MG;10MGTABLET / ORALAARS2001-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040330-001PERCOCET325MG;2.5MGTABLET / ORALAARS1999-06-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040330-002PERCOCET325MG;5MGTABLET / ORALAARS1999-06-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040330-003PERCOCET325MG;7.5MGTABLET / ORALAARS2001-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040330-004PERCOCET325MG;10MGTABLET / ORALAARS2001-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040330-001PERCOCET325MG;2.5MGTABLET / ORALAARS1999-06-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040330-002PERCOCET325MG;5MGTABLET / ORALAARS1999-06-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040330-003PERCOCET325MG;7.5MGTABLET / ORALAARS2001-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040330-004PERCOCET325MG;10MGTABLET / ORALAARS2001-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040330-001PERCOCET325MG;2.5MGTABLET / ORALAARS1999-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040330-002PERCOCET325MG;5MGTABLET / ORALAARS1999-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040330-003PERCOCET325MG;7.5MGTABLET / ORALAARS2001-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040330-004PERCOCET325MG;10MGTABLET / ORALAARS2001-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040330-001PERCOCET325MG;2.5MGTABLET / ORALAARS1999-06-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040330-002PERCOCET325MG;5MGTABLET / ORALAARS1999-06-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040330-003PERCOCET325MG;7.5MGTABLET / ORALAARS2001-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040330-004PERCOCET325MG;10MGTABLET / ORALAARS2001-11-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040330-001PERCOCET325MG;2.5MGTABLET / ORALAARS1999-06-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040330-002PERCOCET325MG;5MGTABLET / ORALAARS1999-06-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040330-003PERCOCET325MG;7.5MGTABLET / ORALAARS2001-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040330-004PERCOCET325MG;10MGTABLET / ORALAARS2001-11-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040330-001PERCOCET325MG;2.5MGTABLET / ORALAARS1999-06-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040330-002PERCOCET325MG;5MGTABLET / ORALAARS1999-06-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040330-003PERCOCET325MG;7.5MGTABLET / ORALAARS2001-11-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040330-004PERCOCET325MG;10MGTABLET / ORALAARS2001-11-23d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040330-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040330-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040330-003AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040330-004AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040330-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040330-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040330-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040330-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040330-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040330-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040330-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040330-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040330-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040330-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040330-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040330-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040330-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040330-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040330-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040330-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040330-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040330-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040330-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040330-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040330-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040330-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040330-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040330-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040330-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040330-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040330-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040330-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040330-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040330-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040330-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040330-004AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040330-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040330-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040330-003AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040330-004AA1d8e5a09893c0…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2189-1ENDOCET500 in 1 BOTTLETABLET500103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2189-1EA - Each63629-2189ced471dc-db65-47e7-9ef1-463e1316940c12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2189ENDOCET (OXYCODONE AND ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240816_029deff5-98f3-4f4c-9f03-d7436dabdf17.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PERCOCETOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSpecGx LLC4dd36cf5-8f73-404a-8b1d-3bd53bd90c252026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040330
application number: ANDA040330
ENDOCETOXYCODONE AND ACETAMINOPHENPar Health USA, LLC944d3e60-7eee-11de-a413-0002a5d5c51b2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040330
application number: ANDA040330
ENDOCETOXYCODONE AND ACETAMINOPHENRedpharm Drug3251c37b-8e31-a613-e063-6294a90ae9822025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040330
application number: ANDA040330
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack7dc10b86-c6cd-4012-b7b9-b694ccf4f7682024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040330
application number: ANDA040330
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackf11f356e-967d-4099-9d87-5497790b397c2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040330
application number: ANDA040330
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c32024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040330
application number: ANDA040330

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049223ENDOCET 5 MG / 325 MG Oral TabletPSN029deff5-98f3-4f4c-9f03-d7436dabdf17103
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN029deff5-98f3-4f4c-9f03-d7436dabdf17103
1049223acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet [Endocet]SBD029deff5-98f3-4f4c-9f03-d7436dabdf17103
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD029deff5-98f3-4f4c-9f03-d7436dabdf17103
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY029deff5-98f3-4f4c-9f03-d7436dabdf17103
1049223APAP 325 MG / Oxycodone Hydrochloride 5 MG Oral Tablet [Endocet]SY029deff5-98f3-4f4c-9f03-d7436dabdf17103
1049223Endocet 5/325 (oxycodone HCl / APAP) Oral TabletSY029deff5-98f3-4f4c-9f03-d7436dabdf17103
1049223Endocet 5/325 Oral TabletSY029deff5-98f3-4f4c-9f03-d7436dabdf17103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2189-163629218901500 TABLET in 1 BOTTLE (63629-2189-1) 500 tablet2000-05-260000-00-00NoNoCurrent