FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
45865-709
11-digit product format
458650709
Labeler code
45865
Product ID
45865-709_9ab3fb67-c23c-40a8-e053-2a95a90aac04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
NDA022370
Marketing category
NDA
Marketing start
2012-03-14
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
150 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
45865-709-302025-01-30C16284748780-12cef2736-84ca-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use Tramadol Hydrochloride Extended-Release safely and effectively. See full prescribing information for Tramadol Hydrochloride Extended-Release. Tramadol Hydrochloride Extended-Release (tramadol hydrochloride) Extended-Release Capsules Initial U.S. Approval: 1995
45865-709-602025-01-30C16284748780-12cef2736-84ca-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use Tramadol Hydrochloride Extended-Release safely and effectively. See full prescribing information for Tramadol Hydrochloride Extended-Release. Tramadol Hydrochloride Extended-Release (tramadol hydrochloride) Extended-Release Capsules Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-709-30Tramadol Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
45865-709-60Tramadol Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BITRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50MTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-709TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_1bbd525e-be01-310d-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248115traMADol HCl 150 MG 24HR Extended Release Oral CapsulePSN1bbd525e-be01-310d-e054-00144ff88e882
124811524 HR tramadol hydrochloride 150 MG Extended Release Oral CapsuleSCD1bbd525e-be01-310d-e054-00144ff88e882
1248115tramadol HCl 150 MG 24 HR Extended Release Oral CapsuleSY1bbd525e-be01-310d-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-709-304586507093030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45865-709-30) 2015-07-270000-00-00NoNoCurrent
45865-709-604586507096060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45865-709-60) 2015-07-270000-00-00NoNoCurrent