FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
63187-063
11-digit product format
631870063
Labeler code
63187
Product ID
63187-063_59d339c1-6ad2-4407-ac41-74e5f4dda6e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076003
Marketing category
ANDA
Marketing start
2010-11-15
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tramadol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui835603

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-063-15Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED157
63187-063-20Tramadol Hydrochloride20 in 1 BOTTLETABLET, COATED207
63187-063-30Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED307
63187-063-40Tramadol Hydrochloride40 in 1 BOTTLETABLET, COATED407
63187-063-60Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED607
63187-063-64Tramadol Hydrochloride240 in 1 BOTTLETABLET, COATED2407
63187-063-72Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED1207
63187-063-78Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED1807
63187-063-90Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-063-15EA - Each63187-0636c75e825-7dc1-41e1-8b73-9dc25e8987ea12017-11-06
63187-063-20EA - Each63187-06332e0ce37-1e0f-47ab-8c55-b57cbca6680212017-07-07
63187-063-30EA - Each63187-063975b5f42-0e9e-499d-aa02-edf1bd6f23a412016-04-04
63187-063-60EA - Each63187-06302aa5934-4b2c-42ea-83cd-92105d1b253f12015-10-02
63187-063-72EA - Each63187-063b202e080-8888-47b5-8519-2373eab67c9d12016-10-06
63187-063-78EA - Each63187-063a089ea55-ac49-44bc-92e6-030182720aa112016-10-06
63187-063-90EA - Each63187-063c6cc3dfc-02c4-4596-a781-f2016af3c59512016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-063TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]7Current NDC, Legacy NDC, 9 package rows20191121_50f4b752-20af-4ebf-9408-e78f30d2a3cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN50f4b752-20af-4ebf-9408-e78f30d2a3cc7
835603tramadol hydrochloride 50 MG Oral TabletSCD50f4b752-20af-4ebf-9408-e78f30d2a3cc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-063-156318700631515 TABLET, COATED in 1 BOTTLE (63187-063-15) 2017-08-010000-00-00NoNoCurrent
63187-063-206318700632020 TABLET, COATED in 1 BOTTLE (63187-063-20) 2016-11-010000-00-00NoNoCurrent
63187-063-306318700633030 TABLET, COATED in 1 BOTTLE (63187-063-30) 2014-05-010000-00-00NoNoCurrent
63187-063-406318700634040 TABLET, COATED in 1 BOTTLE (63187-063-40) 2014-05-010000-00-00NoNoCurrent
63187-063-606318700636060 TABLET, COATED in 1 BOTTLE (63187-063-60) 2014-05-010000-00-00NoNoCurrent
63187-063-6463187006364240 TABLET, COATED in 1 BOTTLE (63187-063-64) 2014-05-010000-00-00NoNoCurrent
63187-063-7263187006372120 TABLET, COATED in 1 BOTTLE (63187-063-72) 2014-05-010000-00-00NoNoCurrent
63187-063-7863187006378180 TABLET, COATED in 1 BOTTLE (63187-063-78) 2014-05-010000-00-00NoNoCurrent
63187-063-906318700639090 TABLET, COATED in 1 BOTTLE (63187-063-90) 2014-05-010000-00-00NoNoCurrent