FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
61919-597
11-digit product format
619190597
Labeler code
61919
Product ID
61919-597_e9ab11b1-6c36-84f7-e053-2995a90aeb1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRX
Application
ANDA090404
Marketing category
ANDA
Marketing start
2020-07-23
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
61919-597-202025-01-30C16284748780-12cef2736-a0a7-d83d-e063-dadaa90ab31fTRAMADOL HYDROCHLORIDE
61919-597-302025-01-30C16284748780-12cef2736-a0a7-d83d-e063-dadaa90ab31fTRAMADOL HYDROCHLORIDE
61919-597-402025-01-30C16284748780-12cef2736-a0a7-d83d-e063-dadaa90ab31fTRAMADOL HYDROCHLORIDE
61919-597-602025-01-30C16284748780-12cef2736-a0a7-d83d-e063-dadaa90ab31fTRAMADOL HYDROCHLORIDE
61919-597-722025-01-30C16284748780-12cef2736-a0a7-d83d-e063-dadaa90ab31fTRAMADOL HYDROCHLORIDE
61919-597-822025-01-30C16284748780-12cef2736-a0a7-d83d-e063-dadaa90ab31fTRAMADOL HYDROCHLORIDE
61919-597-842025-01-30C16284748780-12cef2736-a0a7-d83d-e063-dadaa90ab31fTRAMADOL HYDROCHLORIDE
61919-597-902025-01-30C16284748780-12cef2736-a0a7-d83d-e063-dadaa90ab31fTRAMADOL HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-597-20TRAMADOL HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED207
61919-597-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED307
61919-597-40TRAMADOL HYDROCHLORIDE40 in 1 BOTTLETABLET, FILM COATED407
61919-597-60TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED607
61919-597-72TRAMADOL HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1207
61919-597-82TRAMADOL HYDROCHLORIDE180 in 1 BOTTLETABLET, FILM COATED1807
61919-597-84TRAMADOL HYDROCHLORIDE240 in 1 BOTTLETABLET, FILM COATED2407
61919-597-90TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ATRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-597TRAMADOL HYDROCHLORIDE TABLET, FILM COATED TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]7Legacy NDC, 8 package rows20230608_c34a95e3-d508-428f-9022-19cc5a90b4ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNc34a95e3-d508-428f-9022-19cc5a90b4ec7
835603traMADol HCl 50 MG Oral TabletPSNc34a95e3-d508-428f-9022-19cc5a90b4ec7
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDc34a95e3-d508-428f-9022-19cc5a90b4ec7
835603tramadol hydrochloride 50 MG Oral TabletSCDc34a95e3-d508-428f-9022-19cc5a90b4ec7
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYc34a95e3-d508-428f-9022-19cc5a90b4ec7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-597-206191905972020 TABLET, FILM COATED in 1 BOTTLE (61919-597-20) 2020-07-230000-00-00NoNoCurrent
61919-597-306191905973030 TABLET, FILM COATED in 1 BOTTLE (61919-597-30) 2020-07-230000-00-00NoNoCurrent
61919-597-406191905974040 TABLET, FILM COATED in 1 BOTTLE (61919-597-40) 2020-07-230000-00-00NoNoCurrent
61919-597-606191905976060 TABLET, FILM COATED in 1 BOTTLE (61919-597-60) 2020-07-230000-00-00NoNoCurrent
61919-597-7261919059772120 TABLET, FILM COATED in 1 BOTTLE (61919-597-72) 2020-07-230000-00-00NoNoCurrent
61919-597-8261919059782180 TABLET, FILM COATED in 1 BOTTLE (61919-597-82) 2020-07-230000-00-00NoNoCurrent
61919-597-8461919059784240 TABLET, FILM COATED in 1 BOTTLE (61919-597-84) 2020-07-230000-00-00NoNoCurrent
61919-597-906191905979090 TABLET, FILM COATED in 1 BOTTLE (61919-597-90) 2020-07-230000-00-00NoNoCurrent