FDA.reportPublic FDA data

TRAMADOL HCL

Product NDC
61919-818
11-digit product format
619190818
Labeler code
61919
Product ID
61919-818_24ac4469-6ec1-7d80-e063-6394a90aacf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HCL
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA200503
Marketing category
ANDA
Marketing start
2019-05-03
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 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 HCL
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833709, 833711, 835603

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-818-30TRAMADOL HCLER30 in 1 BOTTLETABLET, EXTENDED RELEASE3018
61919-818-60TRAMADOL HCLER60 in 1 BOTTLETABLET, EXTENDED RELEASE6018
61919-818-90TRAMADOL HCLER90 in 1 BOTTLETABLET, EXTENDED RELEASE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-818-30EA - Each61919-818dfb8f9ce-3a32-48a6-8a5e-007cacb2b6c912020-02-13
61919-818-60EA - Each61919-818558a34fd-5900-41e9-87b6-342d34b012d812019-06-19
61919-818-90EA - Each61919-818c2795e0a-2080-4fa0-bb76-b2be75b6665712024-10-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ATRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-818TRAMADOL HCL ER (TRAMADOL HCL) TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]18Current NDC, Legacy NDC, 3 package rows20241019_5285f056-c32c-4e7a-bec6-3a726aa23d5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN5285f056-c32c-4e7a-bec6-3a726aa23d5a18
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN5285f056-c32c-4e7a-bec6-3a726aa23d5a18
835603traMADol HCl 50 MG Oral TabletPSN5285f056-c32c-4e7a-bec6-3a726aa23d5a18
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD5285f056-c32c-4e7a-bec6-3a726aa23d5a18
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD5285f056-c32c-4e7a-bec6-3a726aa23d5a18
835603tramadol hydrochloride 50 MG Oral TabletSCD5285f056-c32c-4e7a-bec6-3a726aa23d5a18
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY5285f056-c32c-4e7a-bec6-3a726aa23d5a18
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY5285f056-c32c-4e7a-bec6-3a726aa23d5a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-818-306191908183030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-30) 2019-05-030000-00-00NoNoCurrent
61919-818-606191908186060 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-60) 2019-05-030000-00-00NoNoCurrent
61919-818-906191908189090 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-90) 2019-05-03NoNoHistorical