FDA.reportPublic FDA data

ULTRAM ER

Product NDC
21695-913
11-digit product format
216950913
Labeler code
21695
Product ID
21695-913_2fd193e2-7aa7-4119-b540-7e28e82fbd13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021692
Marketing category
NDA
Marketing start
2005-09-08
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
300 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
21695-913-302019-09-24C16284748780-1934fe258-4a25-48b1-e053-8cdaa90a720aULTRAM ® ER (tramadol HCl) Extended-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-913-30ULTRAM ER30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-913-30EA - Each21695-9137287a3da-dc96-494e-9824-cd6d441b9db512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tramadol hydrochlorideACTIVE INGREDIENT9N7R477WCKULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
tramadolACTIVE MOIETY39J1LGJ30JULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
1-VINYL-2-PYRROLIDONEINACTIVE INGREDIENT76H9G81541ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
dibutyl sebacateINACTIVE INGREDIENT4W5IH7FLNYULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-913ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101210_2fd193e2-7aa7-4119-b540-7e28e82fbd13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN2fd193e2-7aa7-4119-b540-7e28e82fbd131
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN2fd193e2-7aa7-4119-b540-7e28e82fbd131
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSN2fd193e2-7aa7-4119-b540-7e28e82fbd131
845314Ultram ER 100 MG 24HR Extended Release Oral TabletPSN2fd193e2-7aa7-4119-b540-7e28e82fbd131
845315Ultram ER 200 MG 24HR Extended Release Oral TabletPSN2fd193e2-7aa7-4119-b540-7e28e82fbd131
845316Ultram ER 300 MG 24HR Extended Release Oral TabletPSN2fd193e2-7aa7-4119-b540-7e28e82fbd131
84531424 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet [Ultram]SBD2fd193e2-7aa7-4119-b540-7e28e82fbd131
84531524 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet [Ultram]SBD2fd193e2-7aa7-4119-b540-7e28e82fbd131
84531624 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet [Ultram]SBD2fd193e2-7aa7-4119-b540-7e28e82fbd131
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD2fd193e2-7aa7-4119-b540-7e28e82fbd131
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD2fd193e2-7aa7-4119-b540-7e28e82fbd131
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCD2fd193e2-7aa7-4119-b540-7e28e82fbd131
84531424 HR Ultram 100 MG Extended Release Oral TabletSY2fd193e2-7aa7-4119-b540-7e28e82fbd131
84531524 HR Ultram 200 MG Extended Release Oral TabletSY2fd193e2-7aa7-4119-b540-7e28e82fbd131
84531624 HR Ultram 300 MG Extended Release Oral TabletSY2fd193e2-7aa7-4119-b540-7e28e82fbd131
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY2fd193e2-7aa7-4119-b540-7e28e82fbd131
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY2fd193e2-7aa7-4119-b540-7e28e82fbd131
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSY2fd193e2-7aa7-4119-b540-7e28e82fbd131
845314Ultram ER 100 MG 24 HR Extended Release Oral TabletSY2fd193e2-7aa7-4119-b540-7e28e82fbd131
845315Ultram ER 200 MG 24 HR Extended Release Oral TabletSY2fd193e2-7aa7-4119-b540-7e28e82fbd131
845316Ultram ER 300 MG 24 HR Extended Release Oral TabletSY2fd193e2-7aa7-4119-b540-7e28e82fbd131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-913-302169509133030 in 1 BOTTLEHistorical