FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
61919-002
11-digit product format
619190002
Labeler code
61919
Product ID
61919-002_0f4b59e9-2438-4aa1-956d-8acc76f51cdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
NDA022370
Marketing category
NDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
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
61919-002-302020-01-31C16284748780-19d75b9d0-9e77-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-002-602020-01-31C16284748780-19d75b9d0-9e77-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-002-722020-01-31C16284748780-19d75b9d0-9e77-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE
61919-002-902020-01-31C16284748780-19d75b9d0-9e77-f424-e053-dadaa90a57ceTRAMADOL HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-002-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLECAPSULE, COATED, EXTENDED RELEAS303
61919-002-60TRAMADOL HYDROCHLORIDE60 in 1 BOTTLECAPSULE, COATED, EXTENDED RELEAS603
61919-002-72TRAMADOL HYDROCHLORIDE100 in 1 BOTTLECAPSULE, COATED, EXTENDED RELEAS1003
61919-002-90TRAMADOL HYDROCHLORIDE90 in 1 BOTTLECAPSULE, COATED, EXTENDED RELEAS903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-002-30EA - Each61919-0027388005e-e820-4572-bd61-364fd14ea6f512014-08-01
61919-002-60EA - Each61919-002f9bc2b28-56f7-4d0f-bc24-345a47e1e2a512014-08-01
61919-002-72EA - Each61919-002ee9189e5-85d0-4d60-9896-cb991ddeb4ee12015-06-09
61919-002-90EA - Each61919-0024dc47050-3f95-4bf9-a086-24efa5ccb5de12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BITRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
GELATININACTIVE INGREDIENT2G86QN327LTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50MTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-002TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]3Legacy NDC, 4 package rows20150514_476ec70a-0737-42ed-a374-c3b9dc0ce5ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248115traMADol HCl 150 MG 24HR Extended Release Oral CapsulePSN476ec70a-0737-42ed-a374-c3b9dc0ce5ca3
124811524 HR tramadol hydrochloride 150 MG Extended Release Oral CapsuleSCD476ec70a-0737-42ed-a374-c3b9dc0ce5ca3
1248115tramadol HCl 150 MG 24 HR Extended Release Oral CapsuleSY476ec70a-0737-42ed-a374-c3b9dc0ce5ca3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-002-306191900023030 in 1 BOTTLEHistorical
61919-002-606191900026060 in 1 BOTTLEHistorical
61919-002-7261919000272100 in 1 BOTTLEHistorical
61919-002-906191900029090 in 1 BOTTLEHistorical