FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
63629-4899
11-digit product format
636294899
Labeler code
63629
Product ID
63629-4899_ce0173f9-1273-4ef9-9391-554b4884bcdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076003
Marketing category
ANDA
Marketing start
2010-11-15
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 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
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
377068df-225f-7318-a910-a1987cdfa361Product name320170608
9457302e-0ca3-d9ff-0863-1b24b6107218Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4899-02024-01-30C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-12024-01-30C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-22024-01-30C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-32024-01-30C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-42024-01-30C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-52024-01-30C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-62024-01-30C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-72024-01-30C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-82024-01-30C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-92024-01-30C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-02020-10-16C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-12020-10-16C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-22020-10-16C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-32020-10-16C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-42020-10-16C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-52020-10-16C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-62020-10-16C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-72020-10-16C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-82020-10-16C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-92020-10-16C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-02020-01-31C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-12020-01-31C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-22020-01-31C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-32020-01-31C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-42020-01-31C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-52020-01-31C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-62020-01-31C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-72020-01-31C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-82020-01-31C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
63629-4899-92020-01-31C16284748780-19d75b9d0-b7dc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4899-0Tramadol Hydrochloride50 in 1 BOTTLETABLET, COATED501011
63629-4899-1Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED301011
63629-4899-2Tramadol Hydrochloride20 in 1 BOTTLETABLET, COATED201011
63629-4899-3Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED901011
63629-4899-4Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED601011
63629-4899-5Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED1201011
63629-4899-6Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED1801011
63629-4899-7Tramadol Hydrochloride40 in 1 BOTTLETABLET, COATED401011
63629-4899-8Tramadol Hydrochloride100 in 1 BOTTLETABLET, COATED1001011
63629-4899-9Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED151011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4899-1EA - Each63629-489956774f03-19c7-4cbc-b9c9-e8a2c870881f12015-10-02
63629-4899-2EA - Each63629-4899f5e5f06f-3080-4fef-a7ac-c16b63ab17ce12015-10-02
63629-4899-3EA - Each63629-48998d306cfe-84ee-4431-b171-aebda55047d812015-10-02
63629-4899-4EA - Each63629-48991b8a38ae-1759-4a6a-a322-2f0f1c86492612015-10-02
63629-4899-5EA - Each63629-4899316dbb1b-5a0b-400c-a3eb-35c88f61e26412015-10-02
63629-4899-6EA - Each63629-48992d39e676-3c60-4369-b240-fff6863ed26112015-10-02
63629-4899-9EA - Each63629-4899b5d030ed-d5a0-49dc-b5cc-78f08a29924912016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4899TRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1011Legacy NDC, 10 package rows20220203_ce0173f9-1273-4ef9-9391-554b4884bcdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNce0173f9-1273-4ef9-9391-554b4884bcdd1011
835603tramadol hydrochloride 50 MG Oral TabletSCDce0173f9-1273-4ef9-9391-554b4884bcdd1011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4899-06362948990050 TABLET, COATED in 1 BOTTLE (63629-4899-0) 2013-02-130000-00-00NoNoCurrent
63629-4899-16362948990130 TABLET, COATED in 1 BOTTLE (63629-4899-1) 2013-02-130000-00-00NoNoCurrent
63629-4899-26362948990220 TABLET, COATED in 1 BOTTLE (63629-4899-2) 2013-02-130000-00-00NoNoCurrent
63629-4899-36362948990390 TABLET, COATED in 1 BOTTLE (63629-4899-3) 2013-02-130000-00-00NoNoCurrent
63629-4899-46362948990460 TABLET, COATED in 1 BOTTLE (63629-4899-4) 2013-02-130000-00-00NoNoCurrent
63629-4899-563629489905120 TABLET, COATED in 1 BOTTLE (63629-4899-5) 2013-02-130000-00-00NoNoCurrent
63629-4899-663629489906180 TABLET, COATED in 1 BOTTLE (63629-4899-6) 2013-02-130000-00-00NoNoCurrent
63629-4899-76362948990740 TABLET, COATED in 1 BOTTLE (63629-4899-7) 2013-02-130000-00-00NoNoCurrent
63629-4899-863629489908100 TABLET, COATED in 1 BOTTLE (63629-4899-8) 2013-02-130000-00-00NoNoCurrent
63629-4899-96362948990915 TABLET, COATED in 1 BOTTLE (63629-4899-9) 2013-02-130000-00-00NoNoCurrent