FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
63629-4901
11-digit product format
636294901
Labeler code
63629
Product ID
63629-4901_28f41a8b-d23d-4c6b-9c0e-340a338a86da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090485
Marketing category
ANDA
Marketing start
2009-12-17
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
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
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
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
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
63629-4901-12024-01-30C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-22024-01-30C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-32024-01-30C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-42024-01-30C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-52024-01-30C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-62024-01-30C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-72024-01-30C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-82024-01-30C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-12022-02-16C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-22022-02-16C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-32022-02-16C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-42022-02-16C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-52022-02-16C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-12019-11-27C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-22019-11-27C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-32019-11-27C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-42019-11-27C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-52019-11-27C16284748780-19855e2a2-448e-60a7-e053-dbdaa90a05bdThese 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
63629-4901-1Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLETABLET301002
63629-4901-2Tramadol Hydrochloride and Acetaminophen60 in 1 BOTTLETABLET601002
63629-4901-3Tramadol Hydrochloride and Acetaminophen90 in 1 BOTTLETABLET901002
63629-4901-4Tramadol Hydrochloride and Acetaminophen120 in 1 BOTTLETABLET1201002
63629-4901-5Tramadol Hydrochloride and Acetaminophen20 in 1 BOTTLETABLET201002
63629-4901-6Tramadol Hydrochloride and Acetaminophen40 in 1 BOTTLETABLET401002
63629-4901-7Tramadol Hydrochloride and Acetaminophen100 in 1 BOTTLETABLET1001002
63629-4901-8Tramadol Hydrochloride and Acetaminophen15 in 1 BOTTLETABLET151002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4901-1EA - Each63629-490174af0e3d-af8b-4778-b067-98ff329b451012015-10-02
63629-4901-2EA - Each63629-4901cb708aba-fd94-407b-b2cc-71d1ca35fe4312015-10-02
63629-4901-3EA - Each63629-4901a697df0b-6c77-4bb5-8443-69598d0c2c9c12015-10-02
63629-4901-4EA - Each63629-4901daadb2a6-ad99-48ad-b48d-306af82646fb12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4901TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1002Legacy NDC, 8 package rows20220217_28f41a8b-d23d-4c6b-9c0e-340a338a86da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN28f41a8b-d23d-4c6b-9c0e-340a338a86da1002
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD28f41a8b-d23d-4c6b-9c0e-340a338a86da1002
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY28f41a8b-d23d-4c6b-9c0e-340a338a86da1002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4901-16362949010130 TABLET in 1 BOTTLE (63629-4901-1) 30 tablet2013-11-250000-00-00NoNoCurrent
63629-4901-26362949010260 TABLET in 1 BOTTLE (63629-4901-2) 60 tablet2013-08-210000-00-00NoNoCurrent
63629-4901-36362949010390 TABLET in 1 BOTTLE (63629-4901-3) 90 tablet2014-06-090000-00-00NoNoCurrent
63629-4901-463629490104120 TABLET in 1 BOTTLE (63629-4901-4) 120 tablet2013-11-150000-00-00NoNoCurrent
63629-4901-56362949010520 TABLET in 1 BOTTLE (63629-4901-5) 20 tablet2014-08-280000-00-00NoNoCurrent
63629-4901-66362949010640 TABLET in 1 BOTTLE (63629-4901-6) 40 tablet2014-12-020000-00-00NoNoCurrent
63629-4901-763629490107100 TABLET in 1 BOTTLE (63629-4901-7) 100 tablet2022-02-150000-00-00NoNoCurrent
63629-4901-86362949010815 TABLET in 1 BOTTLE (63629-4901-8) 15 tablet2022-02-150000-00-00NoNoCurrent