FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
68788-9199
11-digit product format
687889199
Labeler code
68788
Product ID
68788-9199_c7c19978-abae-41e9-bc98-be537cb66676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA076003
Marketing category
ANDA
Marketing start
2009-11-23
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
E
Listing certified through
2017-12-31
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
68788-9199-12020-01-31C16284748780-19d75b9d0-a576-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
68788-9199-22020-01-31C16284748780-19d75b9d0-a576-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
68788-9199-32020-01-31C16284748780-19d75b9d0-a576-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
68788-9199-42020-01-31C16284748780-19d75b9d0-a576-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
68788-9199-52020-01-31C16284748780-19d75b9d0-a576-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
68788-9199-62020-01-31C16284748780-19d75b9d0-a576-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
68788-9199-72020-01-31C16284748780-19d75b9d0-a576-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
68788-9199-82020-01-31C16284748780-19d75b9d0-a576-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
68788-9199-92020-01-31C16284748780-19d75b9d0-a576-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9199-1Tramadol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1005
68788-9199-2Tramadol Hydrochloride20 in 1 BOTTLE, PLASTICTABLET205
68788-9199-3Tramadol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET305
68788-9199-4Tramadol Hydrochloride40 in 1 BOTTLE, PLASTICTABLET405
68788-9199-5Tramadol Hydrochloride15 in 1 BOTTLE, PLASTICTABLET155
68788-9199-6Tramadol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET605
68788-9199-7Tramadol Hydrochloride50 in 1 BOTTLE, PLASTICTABLET505
68788-9199-8Tramadol Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1205
68788-9199-9Tramadol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9199TRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]5Legacy NDC, 9 package rows20160919_94a85fdc-6b17-4af8-a0c9-a7cda7c5a686.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN94a85fdc-6b17-4af8-a0c9-a7cda7c5a6865
835603tramadol hydrochloride 50 MG Oral TabletSCD94a85fdc-6b17-4af8-a0c9-a7cda7c5a6865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-9199-168788919901100 in 1 BOTTLE, PLASTICHistorical
68788-9199-26878891990220 in 1 BOTTLE, PLASTICHistorical
68788-9199-36878891990330 in 1 BOTTLE, PLASTICHistorical
68788-9199-46878891990440 in 1 BOTTLE, PLASTICHistorical
68788-9199-56878891990515 in 1 BOTTLE, PLASTICHistorical
68788-9199-66878891990660 in 1 BOTTLE, PLASTICHistorical
68788-9199-76878891990750 in 1 BOTTLE, PLASTICHistorical
68788-9199-868788919908120 in 1 BOTTLE, PLASTICHistorical
68788-9199-96878891990990 in 1 BOTTLE, PLASTICHistorical