tramadol hydrochloride

Product NDC
50090-0807
11-digit product format
500900807
Labeler code
50090
Product ID
50090-0807_30cb0292-f2cb-467d-b14e-0058d863c0f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075964
Marketing category
ANDA
Marketing start
2002-06-22
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
2022-12-31
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
50090-0807-02023-02-07C16284748780-1f386c64a-26b6-0266-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
50090-0807-12023-02-07C16284748780-1f386c64a-26b6-0266-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
50090-0807-22023-02-07C16284748780-1f386c64a-26b6-0266-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
50090-0807-32023-02-07C16284748780-1f386c64a-26b6-0266-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
50090-0807-42023-02-07C16284748780-1f386c64a-26b6-0266-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
50090-0807-52023-02-07C16284748780-1f386c64a-26b6-0266-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
50090-0807-62023-02-07C16284748780-1f386c64a-26b6-0266-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
50090-0807-02023-01-30C16284748780-1f386c64a-26b6-0266-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
50090-0807-12023-01-30C16284748780-1f386c64a-26b6-0266-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
50090-0807-22023-01-30C16284748780-1f386c64a-26b6-0266-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
50090-0807-32023-01-30C16284748780-1f386c64a-26b6-0266-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
50090-0807-42023-01-30C16284748780-1f386c64a-26b6-0266-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
50090-0807-52023-01-30C16284748780-1f386c64a-26b6-0266-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
50090-0807-62023-01-30C16284748780-1f386c64a-26b6-0266-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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0807-1EA - Each50090-08074adf77ba-eed1-4a5e-b656-f3bb71b475e112018-10-11
50090-0807-2EA - Each50090-0807db13d92a-422c-44a0-821d-e5beef7e245812018-10-11
50090-0807-3EA - Each50090-0807d9e1b137-d234-4fbf-9eab-b9686759385a12018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0807TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]19Legacy NDC20250406_c42fcf3f-9625-469b-b437-486c41d0531b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0807-050090080700240 TABLET in 1 BOTTLE (50090-0807-0) 240 tablet2014-11-280000-00-00NoNoCurrent
50090-0807-15009008070190 TABLET in 1 BOTTLE (50090-0807-1) 90 tablet2014-11-280000-00-00NoNoCurrent
50090-0807-25009008070210 TABLET in 1 BOTTLE (50090-0807-2) 10 tablet2014-11-280000-00-00NoNoCurrent
50090-0807-350090080703180 TABLET in 1 BOTTLE (50090-0807-3) 180 tablet2014-11-280000-00-00NoNoCurrent
50090-0807-45009008070440 TABLET in 1 BOTTLE (50090-0807-4) 40 tablet2014-08-150000-00-00NoNoCurrent
50090-0807-55009008070521 TABLET in 1 BOTTLE (50090-0807-5) 21 tablet2014-08-150000-00-00NoNoCurrent
50090-0807-65009008070628 TABLET in 1 BOTTLE (50090-0807-6) 28 tablet2014-08-150000-00-00NoNoCurrent