FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
61919-073
11-digit product format
619190073
Labeler code
61919
Product ID
61919-073_d554a939-5fac-2c91-e053-2a95a90a36c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA076003
Marketing category
ANDA
Marketing start
2018-06-15
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-073-402021-01-29C16284748780-1ba0f9c33-314a-a910-e053-dadaa90a0b85TRAMADOL HYDROCHLORIDE
61919-073-202020-01-31C16284748780-19d75b9d0-ff04-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-073-302020-01-31C16284748780-19d75b9d0-ff04-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-073-602020-01-31C16284748780-19d75b9d0-ff04-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-073-712020-01-31C16284748780-19d75b9d0-ff04-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-073-722020-01-31C16284748780-19d75b9d0-ff04-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-073-822020-01-31C16284748780-19d75b9d0-ff04-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-073-842020-01-31C16284748780-19d75b9d0-ff04-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-073-902020-01-31C16284748780-19d75b9d0-ff04-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-073-21TRAMADOL HYDROCHLORIDE21 in 1 BOTTLETABLET, COATED2118
61919-073-20TRAMADOL HYDROCHLORIDE20 in 1 BOTTLETABLET, COATED203
61919-073-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, COATED303
61919-073-60TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, COATED603
61919-073-71TRAMADOL HYDROCHLORIDE100 in 1 BOTTLETABLET, COATED1003
61919-073-72TRAMADOL HYDROCHLORIDE120 in 1 BOTTLETABLET, COATED1203
61919-073-82TRAMADOL HYDROCHLORIDE180 in 1 BOTTLETABLET, COATED1803
61919-073-84TRAMADOL HYDROCHLORIDE240 in 1 BOTTLETABLET, COATED2403
61919-073-90TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, COATED903
61919-073-40TRAMADOL HYDROCHLORIDE40 in 1 BOTTLETABLET, COATED401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-073-30EA - Each61919-07380541ac2-ce67-4b7c-885b-fefc77582e3212015-02-02
61919-073-60EA - Each61919-073e268a13d-7d24-4fb2-89db-a59a49e0bec012015-02-02
61919-073-82EA - Each61919-073f7427129-5bff-410d-8af8-d3295a43ec0012015-11-12
61919-073-84EA - Each61919-073d32c51fa-0d87-4517-a1f0-993d4992079012015-02-02
61919-073-90EA - Each61919-073bf2b9bdc-1694-4e8d-bc06-e867ce6dc49912015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ATRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-073TRAMADOL HCL ER (TRAMADOL HCL) TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]18Legacy NDC, 1 package rows20241019_5285f056-c32c-4e7a-bec6-3a726aa23d5a.zip
61919-073TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3Legacy NDC, 8 package rows20151103_4a17d714-9151-4e20-bfab-3deddbf8e04f.zip
61919-073TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT_RX]1Legacy NDC, 1 package rows20190710_8d40dce1-8394-d4a7-e053-2995a90a480a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN5285f056-c32c-4e7a-bec6-3a726aa23d5a18
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN5285f056-c32c-4e7a-bec6-3a726aa23d5a18
835603traMADol HCl 50 MG Oral TabletPSN5285f056-c32c-4e7a-bec6-3a726aa23d5a18
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD5285f056-c32c-4e7a-bec6-3a726aa23d5a18
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD5285f056-c32c-4e7a-bec6-3a726aa23d5a18
835603tramadol hydrochloride 50 MG Oral TabletSCD5285f056-c32c-4e7a-bec6-3a726aa23d5a18
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY5285f056-c32c-4e7a-bec6-3a726aa23d5a18
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY5285f056-c32c-4e7a-bec6-3a726aa23d5a18
835603traMADol HCl 50 MG Oral TabletPSN4a17d714-9151-4e20-bfab-3deddbf8e04f3
835603tramadol hydrochloride 50 MG Oral TabletSCD4a17d714-9151-4e20-bfab-3deddbf8e04f3
835603traMADol HCl 50 MG Oral TabletPSN8d40dce1-8394-d4a7-e053-2995a90a480a1
835603tramadol hydrochloride 50 MG Oral TabletSCD8d40dce1-8394-d4a7-e053-2995a90a480a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-073-206191900732020 in 1 BOTTLEHistorical
61919-073-216191900732121 TABLET, COATED in 1 BOTTLE (61919-073-21) 2018-06-150000-00-00NoNoCurrent
61919-073-306191900733030 in 1 BOTTLEHistorical
61919-073-406191900734040 in 1 BOTTLEHistorical
61919-073-606191900736060 in 1 BOTTLEHistorical
61919-073-7161919007371100 in 1 BOTTLEHistorical
61919-073-7261919007372120 in 1 BOTTLEHistorical
61919-073-8261919007382180 in 1 BOTTLEHistorical
61919-073-8461919007384240 in 1 BOTTLEHistorical
61919-073-906191900739090 in 1 BOTTLEHistorical