FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
53746-203
11-digit product format
537460203
Labeler code
53746
Product ID
53746-203_bb27c9aa-111e-4598-8aa6-3073e42d2e3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040777
Marketing category
ANDA
Marketing start
2007-11-27
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
5; 325 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

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
A040777-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2007-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040777-001AA

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 22:38:342026-08A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-2784e616aacf4f…
2026-08-18 06:07:402026-07A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-273f01610625f2…
2019-09-15 20:21 UTC2019-09A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040777-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2007-11-27f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A040777-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A040777-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040777-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040777-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040777-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040777-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040777-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040777-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040777-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040777-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040777-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040777-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040777-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040777-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040777-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040777-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040777-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040777-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040777-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040777-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040777-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040777-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040777-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040777-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040777-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040777-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040777-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040777-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040777-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040777-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040777-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040777-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040777-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040777-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040777-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040777-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040777-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040777-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040777-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040777-001AA1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Oxycodone and Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1
ACETAMINOPHEN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049221Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
683d563f-0686-4964-8183-cf08758cae71Available on FDA.report

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, Related label table
NDCEffectiveRelated label
53746-203-012024-02-09Oxycodone and Acetaminophen Tablets, USP CII (5 mg / 325 mg)
53746-203-052024-02-09Oxycodone and Acetaminophen Tablets, USP CII (5 mg / 325 mg)
53746-203-012024-01-30Oxycodone and Acetaminophen Tablets, USP CII (5 mg / 325 mg)
53746-203-052024-01-30Oxycodone and Acetaminophen Tablets, USP CII (5 mg / 325 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-203-01Oxycodone and Acetaminophen100 in 1 BOTTLETABLET10039
53746-203-05Oxycodone and Acetaminophen500 in 1 BOTTLETABLET50039

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-203-01EA - Each53746-203319af69c-52dd-4985-b970-228bfa999b2c12012-07-24
53746-203-05EA - Each53746-203d675aa51-e1c1-443f-847c-c6f2c4a2bdae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]6
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]6
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]6
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]6
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]6
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]2
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]2
AcetaminophenACTIVE INGREDIENT362O9ITL9DOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]1
OXYCODONEACTIVE INGREDIENTCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]1
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]1
Oxycodone HydrochlorideACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]1
AcetaminophenACTIVE MOIETY362O9ITL9DOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
OxycodoneACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]1
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-203OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]36Current NDC, Legacy NDC, 2 package rows20240210_683d563f-0686-4964-8183-cf08758cae71.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAvPAK7055acd5-1cbb-397e-e053-2a91aa0a38522026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040777
application number: ANDA040777
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAmneal Pharmaceuticals of New York LLC683d563f-0686-4964-8183-cf08758cae712025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040777
application number: ANDA040777
ndc (product): 53746-203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN683d563f-0686-4964-8183-cf08758cae7139
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD683d563f-0686-4964-8183-cf08758cae7139
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY683d563f-0686-4964-8183-cf08758cae7139
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN7055acd5-1cbb-397e-e053-2a91aa0a38529
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN7055acd5-1cbb-397e-e053-2a91aa0a38529
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSN7055acd5-1cbb-397e-e053-2a91aa0a38529
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD7055acd5-1cbb-397e-e053-2a91aa0a38529
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD7055acd5-1cbb-397e-e053-2a91aa0a38529
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD7055acd5-1cbb-397e-e053-2a91aa0a38529
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY7055acd5-1cbb-397e-e053-2a91aa0a38529
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY7055acd5-1cbb-397e-e053-2a91aa0a38529
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSY7055acd5-1cbb-397e-e053-2a91aa0a38529
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNa4c772dc-32d8-4a53-a7c4-80114df476426
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSNa4c772dc-32d8-4a53-a7c4-80114df476426
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDa4c772dc-32d8-4a53-a7c4-80114df476426
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCDa4c772dc-32d8-4a53-a7c4-80114df476426
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYa4c772dc-32d8-4a53-a7c4-80114df476426
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSYa4c772dc-32d8-4a53-a7c4-80114df476426
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN6b6b766a-9618-4134-9187-2a8e7bdf36652
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN72e126d5-afe4-4dd2-ab69-da135414791a2
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN9ce43ea3-c373-4763-ae13-58459d0c4da72
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD6b6b766a-9618-4134-9187-2a8e7bdf36652
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD72e126d5-afe4-4dd2-ab69-da135414791a2
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD9ce43ea3-c373-4763-ae13-58459d0c4da72
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY6b6b766a-9618-4134-9187-2a8e7bdf36652
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY72e126d5-afe4-4dd2-ab69-da135414791a2
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY9ce43ea3-c373-4763-ae13-58459d0c4da72
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN26c17ac7-64f4-436b-a56d-38d4584959e81
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN20c699bc-0cee-5984-e054-00144ff88e881
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD26c17ac7-64f4-436b-a56d-38d4584959e81
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD20c699bc-0cee-5984-e054-00144ff88e881
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY26c17ac7-64f4-436b-a56d-38d4584959e81
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY20c699bc-0cee-5984-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-203-0153746020301100 TABLET in 1 BOTTLE (53746-203-01) 100 tablet2007-11-270000-00-00NoNoCurrent
53746-203-0553746020305500 TABLET in 1 BOTTLE (53746-203-05) 500 tablet2007-11-270000-00-00NoNoCurrent