FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
50436-8787
11-digit product format
504368787
Labeler code
50436
Product ID
50436-8787_05bf78df-8a5e-4ef5-ba74-3469634ee093
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Unit Dose Services
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
2020-12-31
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
50436-8787-02021-01-29C16284748780-1ba0f9c33-3108-a910-e053-dadaa90a0b85These 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
50436-8787-12021-01-29C16284748780-1ba0f9c33-3108-a910-e053-dadaa90a0b85These 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
50436-8787-22021-01-29C16284748780-1ba0f9c33-3108-a910-e053-dadaa90a0b85These 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
50436-8787-32021-01-29C16284748780-1ba0f9c33-3108-a910-e053-dadaa90a0b85These 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
50436-8787-42021-01-29C16284748780-1ba0f9c33-3108-a910-e053-dadaa90a0b85These 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
50436-8787-52021-01-29C16284748780-1ba0f9c33-3108-a910-e053-dadaa90a0b85These 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
50436-8787-62021-01-29C16284748780-1ba0f9c33-3108-a910-e053-dadaa90a0b85These 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
50436-8787-72021-01-29C16284748780-1ba0f9c33-3108-a910-e053-dadaa90a0b85These 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
50436-8787-82021-01-29C16284748780-1ba0f9c33-3108-a910-e053-dadaa90a0b85These 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
50436-8787-92021-01-29C16284748780-1ba0f9c33-3108-a910-e053-dadaa90a0b85These 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
50436-8787-0Tramadol Hydrochloride50 in 1 BOTTLETABLET, COATED5016
50436-8787-1Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED3016
50436-8787-2Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED9016
50436-8787-3Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED6016
50436-8787-4Tramadol Hydrochloride12 in 1 BOTTLETABLET, COATED1216
50436-8787-5Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED12016
50436-8787-6Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED18016
50436-8787-7Tramadol Hydrochloride45 in 1 BOTTLETABLET, COATED4516
50436-8787-8Tramadol Hydrochloride240 in 1 BOTTLETABLET, COATED24016
50436-8787-9Tramadol Hydrochloride100 in 1 BOTTLETABLET, COATED10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-8787-0EA - Each50436-87873c657616-36b0-4f1f-8f06-cb3be686def012015-05-05
50436-8787-1EA - Each50436-878745b3bfe8-bcb9-4985-8e7c-232f52d3274412012-07-24
50436-8787-2EA - Each50436-8787e7a9f803-0b46-42d9-87bc-fa3b9e63d88212012-07-24
50436-8787-3EA - Each50436-87872e69531b-0afa-4bf1-a0e6-c9d29cd7101612012-07-24
50436-8787-5EA - Each50436-878779eb9f6d-d7ba-4b1b-80a7-f5c984ad4fda12012-07-24
50436-8787-6EA - Each50436-8787a99f96f4-be0d-472b-99fa-f941ab17dcb012012-07-24
50436-8787-7EA - Each50436-878741f7aa41-a4d0-433d-ae89-3d0a85da8d5812012-07-24
50436-8787-8EA - Each50436-87876f60fddd-6db5-4f47-8f35-b84d98a6551e12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-8787TRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]16Legacy NDC, 10 package rows20190531_37ce0483-afde-4859-b160-e81c0ecd5506.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN37ce0483-afde-4859-b160-e81c0ecd550616
835603tramadol hydrochloride 50 MG Oral TabletSCD37ce0483-afde-4859-b160-e81c0ecd550616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-8787-05043687870050 in 1 BOTTLEHistorical
50436-8787-15043687870130 in 1 BOTTLEHistorical
50436-8787-25043687870290 in 1 BOTTLEHistorical
50436-8787-35043687870360 in 1 BOTTLEHistorical
50436-8787-45043687870412 in 1 BOTTLEHistorical
50436-8787-550436878705120 in 1 BOTTLEHistorical
50436-8787-650436878706180 in 1 BOTTLEHistorical
50436-8787-75043687870745 in 1 BOTTLEHistorical
50436-8787-850436878708240 in 1 BOTTLEHistorical
50436-8787-950436878709100 in 1 BOTTLEHistorical