FDA.reportPublic FDA data

Ultram

Product NDC
51655-185
11-digit product format
516550185
Labeler code
51655
Product ID
51655-185_39dcdd81-7699-4582-8a85-f763d7d73e18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HCL
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NORTHWIND PHARMACEUTICALS
Application
ANDA076003
Marketing category
ANDA
Marketing start
2014-02-13
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/201
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-185-202026-01-06C16284748780-19d75b9d0-1e40-f424-e053-dadaa90a57ce3f12e8b3-ccf5-4b7d-a370-9596e5002b10
51655-185-202020-01-31C16284748780-19d75b9d0-1e40-f424-e053-dadaa90a57ce3f12e8b3-ccf5-4b7d-a370-9596e5002b10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKULTRAM (TRAMADOL HCL) TABLET, COATED [NORTHWIND PHARMACEUTICALS]1
TRAMADOLACTIVE MOIETY39J1LGJ30JULTRAM (TRAMADOL HCL) TABLET, COATED [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-185ULTRAM (TRAMADOL HCL) TABLET, COATED [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140310_3f12e8b3-ccf5-4b7d-a370-9596e5002b10.zip