FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
68071-4119
11-digit product format
680714119
Labeler code
68071
Product ID
68071-4119_2d3fca70-2bc9-7bec-e063-6294a90a8da4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4119-12025-02-03C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-32025-02-03C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-42025-02-03C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-52025-02-03C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-62025-02-03C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-72025-02-03C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-82025-02-03C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-92025-02-03C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-12025-01-30C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-32025-01-30C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-42025-01-30C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-52025-01-30C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-62025-01-30C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-72025-01-30C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-82025-01-30C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-92025-01-30C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-12020-09-17C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-32020-09-17C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-42020-09-17C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-52020-09-17C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-62020-09-17C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-72020-09-17C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-82020-09-17C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-92020-09-17C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-12020-01-31C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-32020-01-31C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-42020-01-31C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-52020-01-31C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-62020-01-31C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-72020-01-31C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-82020-01-31C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV
68071-4119-92020-01-31C16284748780-19d75b9cf-dd15-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4119-1Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED1204
68071-4119-3Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED304
68071-4119-4Tramadol Hydrochloride40 in 1 BOTTLETABLET, COATED404
68071-4119-5Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED154
68071-4119-6Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED604
68071-4119-7Tramadol Hydrochloride84 in 1 BOTTLETABLET, COATED844
68071-4119-8Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED1804
68071-4119-9Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4119TRAMADOL HYDROCHLORIDE TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 8 package rows20250205_5babcfcf-331b-5db9-e053-2a91aa0aaf89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN5babcfcf-331b-5db9-e053-2a91aa0aaf894
835603tramadol hydrochloride 50 MG Oral TabletSCD5babcfcf-331b-5db9-e053-2a91aa0aaf894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4119-168071411901120 TABLET, COATED in 1 BOTTLE (68071-4119-1) 2017-10-160000-00-00NoNoCurrent
68071-4119-36807141190330 TABLET, COATED in 1 BOTTLE (68071-4119-3) 2017-10-160000-00-00NoNoCurrent
68071-4119-46807141190440 TABLET, COATED in 1 BOTTLE (68071-4119-4) 2017-10-160000-00-00NoNoCurrent
68071-4119-56807141190515 TABLET, COATED in 1 BOTTLE (68071-4119-5) 2017-10-160000-00-00NoNoCurrent
68071-4119-66807141190660 TABLET, COATED in 1 BOTTLE (68071-4119-6) 2017-10-160000-00-00NoNoCurrent
68071-4119-76807141190784 TABLET, COATED in 1 BOTTLE (68071-4119-7) 2017-10-160000-00-00NoNoCurrent
68071-4119-868071411908180 TABLET, COATED in 1 BOTTLE (68071-4119-8) 2017-10-160000-00-00NoNoCurrent
68071-4119-96807141190990 TABLET, COATED in 1 BOTTLE (68071-4119-9) 2017-10-160000-00-00NoNoCurrent