FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
71610-392
11-digit product format
716100392
Labeler code
71610
Product ID
71610-392_9298ddb2-c8eb-4c15-aef0-a938e0975a3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076003
Marketing category
ANDA
Marketing start
2010-11-15
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
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
71610-392-152023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-202023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-242023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-282023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-302023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-402023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-452023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-462023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-502023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-532023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-542023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-572023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-602023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-652023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-672023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-702023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-722023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-732023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-752023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-802023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-852023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-902023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
71610-392-942023-01-30C16284748780-1f386c64a-0d1a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-392-15Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED151
71610-392-20Tramadol Hydrochloride20 in 1 BOTTLETABLET, COATED201
71610-392-24Tramadol Hydrochloride224 in 1 BOTTLETABLET, COATED2241
71610-392-28Tramadol Hydrochloride28 in 1 BOTTLETABLET, COATED281
71610-392-30Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED301
71610-392-40Tramadol Hydrochloride40 in 1 BOTTLETABLET, COATED401
71610-392-45Tramadol Hydrochloride45 in 1 BOTTLETABLET, COATED451
71610-392-46Tramadol Hydrochloride56 in 1 BOTTLETABLET, COATED561
71610-392-50Tramadol Hydrochloride50 in 1 BOTTLETABLET, COATED501
71610-392-53Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED601
71610-392-54Tramadol Hydrochloride84 in 1 BOTTLETABLET, COATED841
71610-392-57Tramadol Hydrochloride80 in 1 BOTTLETABLET, COATED801
71610-392-60Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED901
71610-392-65Tramadol Hydrochloride100 in 1 BOTTLETABLET, COATED1001
71610-392-67Tramadol Hydrochloride168 in 1 BOTTLETABLET, COATED1681
71610-392-70Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED1201
71610-392-72Tramadol Hydrochloride112 in 1 BOTTLETABLET, COATED1121
71610-392-73Tramadol Hydrochloride135 in 1 BOTTLETABLET, COATED1351
71610-392-75Tramadol Hydrochloride150 in 1 BOTTLETABLET, COATED1501
71610-392-80Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED1801
71610-392-85Tramadol Hydrochloride200 in 1 BOTTLETABLET, COATED2001
71610-392-90Tramadol Hydrochloride240 in 1 BOTTLETABLET, COATED2401
71610-392-94Tramadol Hydrochloride360 in 1 BOTTLETABLET, COATED3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-392-15EA - Each71610-39208c80734-b411-47e1-80a7-24e80fdb6a7c12020-04-20
71610-392-20EA - Each71610-392b4243d4c-0751-4aa7-81cf-55b2549ded8c12020-04-20
71610-392-24EA - Each71610-392ba41f1ee-c205-48c3-bdf6-34e92317bbc012020-04-20
71610-392-28EA - Each71610-392343b79ff-d050-4bdf-a63b-aeb7e76b80d612020-04-20
71610-392-30EA - Each71610-392ca6d54ea-1f33-452d-b1fc-4d705df90b6112020-04-20
71610-392-40EA - Each71610-3921a78911b-5f35-4837-bc0b-491bd7e2daab12020-04-20
71610-392-45EA - Each71610-3921a8c1b16-ecc9-47fd-aee6-442b6bf790be12020-04-20
71610-392-46EA - Each71610-39218fce50b-b3e2-4e1d-8dba-475219d34a4a12020-04-20
71610-392-50EA - Each71610-392a055afdd-ddec-45d0-9acd-eba1278097b012020-04-20
71610-392-53EA - Each71610-39265fef699-a636-4ba8-923f-d22c5198be0912020-04-20
71610-392-54EA - Each71610-392ed3f3e7a-c38a-44f4-907d-f0287313e30712020-04-20
71610-392-57EA - Each71610-392665d0271-9600-4fbf-9413-bf7592621b5212020-04-20
71610-392-60EA - Each71610-392f172918b-2cf0-4be8-a69d-82e491f4ebaa12020-04-20
71610-392-65EA - Each71610-392c45dfd15-a186-4381-a613-c681f6f220a012020-04-20
71610-392-67EA - Each71610-392f3f03428-684a-4a47-96d6-b37ad27ff1d712020-04-20
71610-392-70EA - Each71610-39254194161-2951-4a1a-8402-f4ccd4c5166712020-04-20
71610-392-72EA - Each71610-3928cefaf5c-cf14-44fe-a3ca-e3694ae8be7d12020-04-20
71610-392-73EA - Each71610-392f23ad638-6fcf-4c7d-b21b-53aa4cfecaf112020-04-20
71610-392-75EA - Each71610-39281a3c8a8-60da-418d-9033-73f1cc0b7ca512020-04-20
71610-392-85EA - Each71610-3920f341891-9af0-48d8-9017-70a9bdb477b912020-04-20
71610-392-90EA - Each71610-39247147a3d-42d5-41ae-bfb5-0ec0e591ac0a12020-04-20
71610-392-94EA - Each71610-39289204240-9d23-4150-978d-2f9cc3776e3412020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-392TRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 23 package rows20200303_ac0b0590-e280-4d20-8238-61e7d4b0d2f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNac0b0590-e280-4d20-8238-61e7d4b0d2f31
835603tramadol hydrochloride 50 MG Oral TabletSCDac0b0590-e280-4d20-8238-61e7d4b0d2f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-392-157161003921515 TABLET, COATED in 1 BOTTLE (71610-392-15) 2020-01-280000-00-00NoNoCurrent
71610-392-207161003922020 TABLET, COATED in 1 BOTTLE (71610-392-20) 2020-01-280000-00-00NoNoCurrent
71610-392-2471610039224224 TABLET, COATED in 1 BOTTLE (71610-392-24) 2020-01-280000-00-00NoNoCurrent
71610-392-287161003922828 TABLET, COATED in 1 BOTTLE (71610-392-28) 2020-01-280000-00-00NoNoCurrent
71610-392-307161003923030 TABLET, COATED in 1 BOTTLE (71610-392-30) 2020-01-280000-00-00NoNoCurrent
71610-392-407161003924040 TABLET, COATED in 1 BOTTLE (71610-392-40) 2020-01-280000-00-00NoNoCurrent
71610-392-457161003924545 TABLET, COATED in 1 BOTTLE (71610-392-45) 2020-01-280000-00-00NoNoCurrent
71610-392-467161003924656 TABLET, COATED in 1 BOTTLE (71610-392-46) 2020-01-280000-00-00NoNoCurrent
71610-392-507161003925050 TABLET, COATED in 1 BOTTLE (71610-392-50) 2020-01-280000-00-00NoNoCurrent
71610-392-537161003925360 TABLET, COATED in 1 BOTTLE (71610-392-53) 2020-01-280000-00-00NoNoCurrent
71610-392-547161003925484 TABLET, COATED in 1 BOTTLE (71610-392-54) 2020-01-280000-00-00NoNoCurrent
71610-392-577161003925780 TABLET, COATED in 1 BOTTLE (71610-392-57) 2020-01-280000-00-00NoNoCurrent
71610-392-607161003926090 TABLET, COATED in 1 BOTTLE (71610-392-60) 2020-01-280000-00-00NoNoCurrent
71610-392-6571610039265100 TABLET, COATED in 1 BOTTLE (71610-392-65) 2020-01-280000-00-00NoNoCurrent
71610-392-6771610039267168 TABLET, COATED in 1 BOTTLE (71610-392-67) 2020-01-280000-00-00NoNoCurrent
71610-392-7071610039270120 TABLET, COATED in 1 BOTTLE (71610-392-70) 2020-01-280000-00-00NoNoCurrent
71610-392-7271610039272112 TABLET, COATED in 1 BOTTLE (71610-392-72) 2020-01-280000-00-00NoNoCurrent
71610-392-7371610039273135 TABLET, COATED in 1 BOTTLE (71610-392-73) 2020-01-280000-00-00NoNoCurrent
71610-392-7571610039275150 TABLET, COATED in 1 BOTTLE (71610-392-75) 2020-01-280000-00-00NoNoCurrent
71610-392-8071610039280180 TABLET, COATED in 1 BOTTLE (71610-392-80) 2020-01-280000-00-00NoNoCurrent
71610-392-8571610039285200 TABLET, COATED in 1 BOTTLE (71610-392-85) 2020-01-280000-00-00NoNoCurrent
71610-392-9071610039290240 TABLET, COATED in 1 BOTTLE (71610-392-90) 2020-01-280000-00-00NoNoCurrent
71610-392-9471610039294360 TABLET, COATED in 1 BOTTLE (71610-392-94) 2020-01-300000-00-00NoNoCurrent