FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
50090-5789
11-digit product format
500905789
Labeler code
50090
Product ID
50090-5789_d2130333-f392-4f3c-b988-c4147c6c9595
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211825
Marketing category
ANDA
Marketing start
2019-08-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tramadol Hydrochloride
Listing expiration
2027-12-31

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
50090-5789-02023-02-07C16284748780-1f386c649-eef8-0266-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.
50090-5789-12023-02-07C16284748780-1f386c649-eef8-0266-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.
50090-5789-22023-02-07C16284748780-1f386c649-eef8-0266-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.
50090-5789-32023-02-07C16284748780-1f386c649-eef8-0266-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.
50090-5789-42023-02-07C16284748780-1f386c649-eef8-0266-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.
50090-5789-52023-02-07C16284748780-1f386c649-eef8-0266-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.
50090-5789-92023-02-07C16284748780-1f386c649-eef8-0266-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.
50090-5789-02023-01-30C16284748780-1f386c649-eef8-0266-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.
50090-5789-12023-01-30C16284748780-1f386c649-eef8-0266-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.
50090-5789-22023-01-30C16284748780-1f386c649-eef8-0266-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.
50090-5789-32023-01-30C16284748780-1f386c649-eef8-0266-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.
50090-5789-42023-01-30C16284748780-1f386c649-eef8-0266-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.
50090-5789-52023-01-30C16284748780-1f386c649-eef8-0266-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.
50090-5789-92023-01-30C16284748780-1f386c649-eef8-0266-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
50090-5789-0Tramadol Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3013
50090-5789-1Tramadol Hydrochloride20 in 1 BOTTLETABLET, FILM COATED2013
50090-5789-2Tramadol Hydrochloride50 in 1 BOTTLETABLET, FILM COATED5013
50090-5789-3Tramadol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10013
50090-5789-4Tramadol Hydrochloride15 in 1 BOTTLETABLET, FILM COATED1513
50090-5789-5Tramadol Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6013
50090-5789-9Tramadol Hydrochloride120 in 1 BOTTLETABLET, FILM COATED12013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5789TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 7 package rows20240604_f9282800-fde7-477a-8b8f-59617ec26f73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNf9282800-fde7-477a-8b8f-59617ec26f7313
835603tramadol hydrochloride 50 MG Oral TabletSCDf9282800-fde7-477a-8b8f-59617ec26f7313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5789-05009057890030 TABLET, FILM COATED in 1 BOTTLE (50090-5789-0) 2021-10-080000-00-00NoNoCurrent
50090-5789-15009057890120 TABLET, FILM COATED in 1 BOTTLE (50090-5789-1) 2021-10-080000-00-00NoNoCurrent
50090-5789-25009057890250 TABLET, FILM COATED in 1 BOTTLE (50090-5789-2) 2021-10-080000-00-00NoNoCurrent
50090-5789-350090578903100 TABLET, FILM COATED in 1 BOTTLE (50090-5789-3) 2021-10-080000-00-00NoNoCurrent
50090-5789-45009057890415 TABLET, FILM COATED in 1 BOTTLE (50090-5789-4) 2021-10-080000-00-00NoNoCurrent
50090-5789-55009057890560 TABLET, FILM COATED in 1 BOTTLE (50090-5789-5) 2021-10-080000-00-00NoNoCurrent
50090-5789-950090578909120 TABLET, FILM COATED in 1 BOTTLE (50090-5789-9) 2021-10-080000-00-00NoNoCurrent