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
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
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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, C1ENJ2TE6C
Rxcui1049221

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
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20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
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a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
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bde672ba-4805-28d0-1986-73543d41b412Product name220210201
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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
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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
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c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
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f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53746-203-012024-02-09C16284748780-11030e365-2483-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII (5 mg / 325 mg)
53746-203-052024-02-09C16284748780-11030e365-2483-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII (5 mg / 325 mg)
53746-203-012024-01-30C16284748780-11030e365-2483-111a-e063-dadaa90a10e2Oxycodone and Acetaminophen Tablets, USP CII (5 mg / 325 mg)
53746-203-052024-01-30C16284748780-11030e365-2483-111a-e063-dadaa90a10e2Oxycodone 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 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

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