FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
53746-204
11-digit product format
537460204
Labeler code
53746
Product ID
53746-204_be8f26ed-3ee9-4a9f-b300-8c7654a84ceb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040778
Marketing category
ANDA
Marketing start
2007-11-27
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 10 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
OXYCODONE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, C1ENJ2TE6C
Rxcui1049214

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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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
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07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
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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
53746-204-012024-02-09C16284748780-11030e365-4c78-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII (10 mg / 325 mg)
53746-204-012024-02-09C16284748780-11030e365-4c78-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII (10 mg / 325 mg)
53746-204-052024-02-09C16284748780-11030e365-4c78-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII (10 mg / 325 mg)
53746-204-052024-02-09C16284748780-11030e365-4c78-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII (10 mg / 325 mg)
53746-204-012024-01-30C16284748780-11030e365-4c78-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII (10 mg / 325 mg)
53746-204-012024-01-30C16284748780-11030e365-4c78-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII (10 mg / 325 mg)
53746-204-052024-01-30C16284748780-11030e365-4c78-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII (10 mg / 325 mg)
53746-204-052024-01-30C16284748780-11030e365-4c78-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII (10 mg / 325 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-204-01Oxycodone and Acetaminophen100 in 1 BOTTLETABLET10037
53746-204-05Oxycodone and Acetaminophen500 in 1 BOTTLETABLET50037

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-204OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]34Current NDC, Legacy NDC, 2 package rows20240316_d61e0ff4-e04b-4dc6-b818-6a8f46e99b5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNd61e0ff4-e04b-4dc6-b818-6a8f46e99b5e37
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDd61e0ff4-e04b-4dc6-b818-6a8f46e99b5e37
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYd61e0ff4-e04b-4dc6-b818-6a8f46e99b5e37
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
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN6253b3ae-bb52-4532-8d1f-756c0b1577c74
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD6253b3ae-bb52-4532-8d1f-756c0b1577c74
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY6253b3ae-bb52-4532-8d1f-756c0b1577c74
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNa6cce10a-23ba-4eb1-9b1b-0f962f42df812
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDa6cce10a-23ba-4eb1-9b1b-0f962f42df812
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYa6cce10a-23ba-4eb1-9b1b-0f962f42df812
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN0d0dbb74-4a2c-4a95-b81e-6d008cd888081
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD0d0dbb74-4a2c-4a95-b81e-6d008cd888081
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY0d0dbb74-4a2c-4a95-b81e-6d008cd888081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-204-0153746020401100 TABLET in 1 BOTTLE (53746-204-01) 100 tablet2007-11-270000-00-00NoNoCurrent
53746-204-0553746020405500 TABLET in 1 BOTTLE (53746-204-05) 500 tablet2007-11-270000-00-00NoNoCurrent