FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
49884-822
11-digit product format
498840822
Labeler code
49884
Product ID
49884-822_54947c89-5c47-4f58-8970-9d4321cf18d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA078783
Marketing category
ANDA
Marketing start
2012-06-28
Marketing end
2019-03-31
Substance
TRAMADOL HYDROC
Active strength
200 mg/1
Pharmacologic classes
Full Opioid Ago
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-822-11EA - Each49884-822ab306fd9-c14f-40ec-be77-f3e2c2a3531112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL ER TABLET, EXTENDED RELEASE [STAT RX USA]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL ER TABLET, EXTENDED RELEASE [STAT RX USA]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN322513fd-6be0-4cd9-a0ea-7e4b5b5783362
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN0f799e5c-f782-4f3d-bdb6-52bd413a19cf2
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN322513fd-6be0-4cd9-a0ea-7e4b5b5783362
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD322513fd-6be0-4cd9-a0ea-7e4b5b5783362
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD0f799e5c-f782-4f3d-bdb6-52bd413a19cf2
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD322513fd-6be0-4cd9-a0ea-7e4b5b5783362
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY0f799e5c-f782-4f3d-bdb6-52bd413a19cf2
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY322513fd-6be0-4cd9-a0ea-7e4b5b5783362
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY322513fd-6be0-4cd9-a0ea-7e4b5b5783362
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