FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
21695-700
11-digit product format
216950700
Labeler code
21695
Product ID
21695-700_f4fdfd83-c078-424b-9b46-d175c8e7f726
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA078783
Marketing category
ANDA
Marketing start
2009-11-13
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
200 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
21695-700-302019-09-24C16284748780-1934fe258-496b-48b1-e053-8cdaa90a720aRX Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-700-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-700-30EA - Each21695-700d7d66162-3117-4865-9418-94e020f4e73612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-700TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100713_246a45d0-0953-4f4f-8175-dab3bafac2db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN246a45d0-0953-4f4f-8175-dab3bafac2db1
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN246a45d0-0953-4f4f-8175-dab3bafac2db1
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD246a45d0-0953-4f4f-8175-dab3bafac2db1
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD246a45d0-0953-4f4f-8175-dab3bafac2db1
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY246a45d0-0953-4f4f-8175-dab3bafac2db1
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY246a45d0-0953-4f4f-8175-dab3bafac2db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-700-302169507003030 in 1 BOTTLE, PLASTICHistorical