FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
53746-617
11-digit product format
537460617
Labeler code
53746
Product ID
53746-617_90386181-256c-422d-8f7e-1bf0959b69bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA090485
Marketing category
ANDA
Marketing start
2009-12-17
Substance
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength
325; 37.5 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
TRAMADOL HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9N7R477WCK
Rxcui836395

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
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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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
9457302e-0ca3-d9ff-0863-1b24b6107218Product 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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d5c49867-1fe9-7a44-3319-814417011d51Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53746-617-012021-02-09C16284748780-1ba0f9c33-3ee8-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001
53746-617-052021-02-09C16284748780-1ba0f9c33-3ee8-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001
53746-617-102021-02-09C16284748780-1ba0f9c33-3ee8-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001
53746-617-302021-02-09C16284748780-1ba0f9c33-3ee8-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001
53746-617-012021-01-29C16284748780-1ba0f9c33-3ee8-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001
53746-617-052021-01-29C16284748780-1ba0f9c33-3ee8-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001
53746-617-102021-01-29C16284748780-1ba0f9c33-3ee8-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001
53746-617-302021-01-29C16284748780-1ba0f9c33-3ee8-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-617-01Tramadol Hydrochloride and Acetaminophen100 in 1 BOTTLETABLET10034
53746-617-05Tramadol Hydrochloride and Acetaminophen500 in 1 BOTTLETABLET50034
53746-617-10Tramadol Hydrochloride and Acetaminophen1000 in 1 BOTTLETABLET100034
53746-617-30Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLETABLET3034

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-617TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]30Current NDC, Legacy NDC, 4 package rows20240302_d51600e2-2f73-483c-9b2e-f142bafff16d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNd51600e2-2f73-483c-9b2e-f142bafff16d34
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDd51600e2-2f73-483c-9b2e-f142bafff16d34
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYd51600e2-2f73-483c-9b2e-f142bafff16d34
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNf33fcd05-2c95-48dd-884b-5ed9c25c2ccf9
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDf33fcd05-2c95-48dd-884b-5ed9c25c2ccf9
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYf33fcd05-2c95-48dd-884b-5ed9c25c2ccf9
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN2014e1b4-4c8d-4909-ad16-21d89925bf558
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD2014e1b4-4c8d-4909-ad16-21d89925bf558
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY2014e1b4-4c8d-4909-ad16-21d89925bf558
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f06
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f06
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f06
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN96094578-5348-4955-8e91-1c9163315d5a5
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD96094578-5348-4955-8e91-1c9163315d5a5
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY96094578-5348-4955-8e91-1c9163315d5a5
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN1ad89537-3e59-438c-b646-b3c93b7908534
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD1ad89537-3e59-438c-b646-b3c93b7908534
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY1ad89537-3e59-438c-b646-b3c93b7908534
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN9b600839-6c1b-4000-a9c5-efd74586a68a2
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN4e40f55e-1d8e-ce2f-e063-6294a90a7bec2
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN1b67c155-5a0d-2202-e054-00144ff8d46c2
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD4e40f55e-1d8e-ce2f-e063-6294a90a7bec2
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD9b600839-6c1b-4000-a9c5-efd74586a68a2
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD1b67c155-5a0d-2202-e054-00144ff8d46c2
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY4e40f55e-1d8e-ce2f-e063-6294a90a7bec2
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY9b600839-6c1b-4000-a9c5-efd74586a68a2
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY1b67c155-5a0d-2202-e054-00144ff8d46c2
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN52693021-f60f-43bc-9b05-43db186213461
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD52693021-f60f-43bc-9b05-43db186213461
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY52693021-f60f-43bc-9b05-43db186213461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-617-0153746061701100 TABLET in 1 BOTTLE (53746-617-01) 100 tablet2009-12-170000-00-00NoNoCurrent
53746-617-0553746061705500 TABLET in 1 BOTTLE (53746-617-05) 500 tablet2009-12-170000-00-00NoNoCurrent
53746-617-10537460617101000 TABLET in 1 BOTTLE (53746-617-10) 1000 tablet2009-12-170000-00-00NoNoCurrent
53746-617-305374606173030 TABLET in 1 BOTTLE (53746-617-30) 30 tablet2009-12-170000-00-00NoNoCurrent