FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
12634-786
11-digit product format
126340786
Labeler code
12634
Product ID
12634-786_2709bacb-b51c-124d-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
APOTHECA, INC
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
2019-12-31
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
12634-786-002020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-012020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-502020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-522020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-542020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-552020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-572020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-592020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-602020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-612020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-622020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-652020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-662020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-712020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-792020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-802020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-812020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-852020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-902020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-912020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg
12634-786-962020-01-31C16284748780-19d75b9d0-5437-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP 50mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-786-00TRAMADOL HYDROCHLORIDE10 in 1 BOTTLETABLET106
12634-786-01TRAMADOL HYDROCHLORIDE100 in 1 BOTTLETABLET1006
12634-786-50TRAMADOL HYDROCHLORIDE50 in 1 BOTTLETABLET506
12634-786-52TRAMADOL HYDROCHLORIDE12 in 1 BLISTER PACKTABLET126
12634-786-54TRAMADOL HYDROCHLORIDE14 in 1 BLISTER PACKTABLET146
12634-786-55TRAMADOL HYDROCHLORIDE15 in 1 BLISTER PACKTABLET156
12634-786-57TRAMADOL HYDROCHLORIDE20 in 1 BLISTER PACKTABLET206
12634-786-59TRAMADOL HYDROCHLORIDE30 in 1 BLISTER PACKTABLET306
12634-786-60TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET606
12634-786-61TRAMADOL HYDROCHLORIDE10 in 1 BLISTER PACKTABLET106
12634-786-62TRAMADOL HYDROCHLORIDE2 in 1 BLISTER PACKTABLET26
12634-786-65TRAMADOL HYDROCHLORIDE5 in 1 BLISTER PACKTABLET56
12634-786-66TRAMADOL HYDROCHLORIDE6 in 1 BLISTER PACKTABLET66
12634-786-71TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET306
12634-786-79TRAMADOL HYDROCHLORIDE25 in 1 BOTTLETABLET256
12634-786-80TRAMADOL HYDROCHLORIDE20 in 1 BOTTLETABLET206
12634-786-81TRAMADOL HYDROCHLORIDE21 in 1 BOTTLETABLET216
12634-786-85TRAMADOL HYDROCHLORIDE15 in 1 BOTTLETABLET156
12634-786-90TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET906
12634-786-91TRAMADOL HYDROCHLORIDE1 in 1 BLISTER PACKTABLET16
12634-786-96TRAMADOL HYDROCHLORIDE6 in 1 BOTTLETABLET66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12634-786-60EA - Each12634-7868fd23a3f-3cb0-4562-86ca-b2cf95d56afe12015-10-02
12634-786-71EA - Each12634-78678d62383-c770-4978-8f52-b1832643b3ce12015-10-02
12634-786-80EA - Each12634-7869adb513d-9055-4ddd-a02d-b744ee96542112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-786TRAMADOL HYDROCHLORIDE TABLET [APOTHECA, INC]6Legacy NDC, 21 package rows20160126_dddcfc5c-e97c-494d-ab17-046455abbb4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNdddcfc5c-e97c-494d-ab17-046455abbb4a6
835603tramadol hydrochloride 50 MG Oral TabletSCDdddcfc5c-e97c-494d-ab17-046455abbb4a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-786-001263407860010 in 1 BOTTLEHistorical
12634-786-0112634078601100 in 1 BOTTLEHistorical
12634-786-501263407865050 in 1 BOTTLEHistorical
12634-786-521263407865212 in 1 BLISTER PACKHistorical
12634-786-541263407865414 in 1 BLISTER PACKHistorical
12634-786-551263407865515 in 1 BLISTER PACKHistorical
12634-786-571263407865720 in 1 BLISTER PACKHistorical
12634-786-591263407865930 in 1 BLISTER PACKHistorical
12634-786-601263407866060 in 1 BOTTLEHistorical
12634-786-611263407866110 in 1 BLISTER PACKHistorical
12634-786-62126340786622 in 1 BLISTER PACKHistorical
12634-786-65126340786655 in 1 BLISTER PACKHistorical
12634-786-66126340786666 in 1 BLISTER PACKHistorical
12634-786-711263407867130 in 1 BOTTLEHistorical
12634-786-791263407867925 in 1 BOTTLEHistorical
12634-786-801263407868020 in 1 BOTTLEHistorical
12634-786-811263407868121 in 1 BOTTLEHistorical
12634-786-851263407868515 in 1 BOTTLEHistorical
12634-786-901263407869090 in 1 BOTTLEHistorical
12634-786-91126340786911 in 1 BLISTER PACKHistorical
12634-786-96126340786966 in 1 BOTTLEHistorical