Tramadol Hydrochloride

Product NDC
65162-627
11-digit product format
651620627
Labeler code
65162
Product ID
65162-627_b0cfacfd-b823-4d43-93cc-2c30baa39fe5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65162-627-012023-02-01C16284748780-1f386c649-f5c2-0266-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
65162-627-102023-02-01C16284748780-1f386c649-f5c2-0266-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
65162-627-112023-02-01C16284748780-1f386c649-f5c2-0266-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
65162-627-502023-02-01C16284748780-1f386c649-f5c2-0266-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
65162-627-012023-01-30C16284748780-1f386c649-f5c2-0266-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
65162-627-102023-01-30C16284748780-1f386c649-f5c2-0266-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
65162-627-112023-01-30C16284748780-1f386c649-f5c2-0266-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
65162-627-502023-01-30C16284748780-1f386c649-f5c2-0266-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
65162-627-01Tramadol Hydrochloride10 in 1 BOTTLETABLET, COATED1034
65162-627-10Tramadol Hydrochloride100 in 1 BOTTLETABLET, COATED10034
65162-627-11Tramadol Hydrochloride1000 in 1 BOTTLETABLET, COATED100034
65162-627-50Tramadol Hydrochloride500 in 1 BOTTLETABLET, COATED50034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-627-10EA - Each65162-6271a7b789b-f0be-449c-b59e-d0009985d78312013-02-13
65162-627-11EA - Each65162-627d4075e45-9ccb-47be-b14a-2c631a905cbe12012-07-24
65162-627-50EA - Each65162-627375ca1a7-cb42-414c-9bf4-e65d3ebdbf2512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]1006
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
TRAMADOLACTIVE MOIETY39J1LGJ30JTHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
GELATININACTIVE INGREDIENT2G86QN327LTHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [READYMEDS]11
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [READYMEDS]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [READYMEDS]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [READYMEDS]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [READYMEDS]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [READYMEDS]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [READYMEDS]11
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [READYMEDS]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [READYMEDS]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [READYMEDS]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [READYMEDS]11
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]9
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]6
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]6
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]6
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]6
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
GELATININACTIVE INGREDIENT2G86QN327LTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [DIRECT RX]3
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [REMEDYREPACK INC. ]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [ALTURA PHARMACEUTICALS, INC.]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [REMEDYREPACK INC. ]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [ALTURA PHARMACEUTICALS, INC.]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-627TRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS LLC]34Current NDC, Legacy NDC, 4 package rows20241105_58b802cb-2443-4f5b-9718-7d54c6d50cb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNce0173f9-1273-4ef9-9391-554b4884bcdd1011
835603tramadol hydrochloride 50 MG Oral TabletSCDce0173f9-1273-4ef9-9391-554b4884bcdd1011
835603traMADol HCl 50 MG Oral TabletPSN58b802cb-2443-4f5b-9718-7d54c6d50cb434
835603tramadol hydrochloride 50 MG Oral TabletSCD58b802cb-2443-4f5b-9718-7d54c6d50cb434
835603traMADol HCl 50 MG Oral TabletPSNb4a17a69-e764-456c-8aa9-d31221c86a6b22
835603tramadol hydrochloride 50 MG Oral TabletSCDb4a17a69-e764-456c-8aa9-d31221c86a6b22
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
835603traMADol HCl 50 MG Oral TabletPSN37ce0483-afde-4859-b160-e81c0ecd550616
835603tramadol hydrochloride 50 MG Oral TabletSCD37ce0483-afde-4859-b160-e81c0ecd550616
835603traMADol HCl 50 MG Oral TabletPSN68b8197c-eb86-4bb4-84bd-45cc9c048c4911
835603tramadol hydrochloride 50 MG Oral TabletSCD68b8197c-eb86-4bb4-84bd-45cc9c048c4911
835603traMADol HCl 50 MG Oral TabletPSNaf87fc31-07c2-b1f7-e053-2995a90a499f9
835603tramadol hydrochloride 50 MG Oral TabletSCDaf87fc31-07c2-b1f7-e053-2995a90a499f9
835603traMADol HCl 50 MG Oral TabletPSN50f4b752-20af-4ebf-9408-e78f30d2a3cc7
835603tramadol hydrochloride 50 MG Oral TabletSCD50f4b752-20af-4ebf-9408-e78f30d2a3cc7
835603traMADol HCl 50 MG Oral TabletPSN54662ff4-10d8-425f-a2ae-978715093da16
835603traMADol HCl 50 MG Oral TabletPSN1a545dca-978d-4091-9917-9074cf6957b26
835603traMADol HCl 50 MG Oral TabletPSNdddcfc5c-e97c-494d-ab17-046455abbb4a6
835603tramadol hydrochloride 50 MG Oral TabletSCD54662ff4-10d8-425f-a2ae-978715093da16
835603tramadol hydrochloride 50 MG Oral TabletSCD1a545dca-978d-4091-9917-9074cf6957b26
835603tramadol hydrochloride 50 MG Oral TabletSCDdddcfc5c-e97c-494d-ab17-046455abbb4a6
835603traMADol HCl 50 MG Oral TabletPSN1279bffe-3494-4016-803c-abbf8fd8f0235
835603traMADol HCl 50 MG Oral TabletPSN94a85fdc-6b17-4af8-a0c9-a7cda7c5a6865
835603traMADol HCl 50 MG Oral TabletPSN402ff644-9f7b-46f3-b62c-d0f031575a405
835603tramadol hydrochloride 50 MG Oral TabletSCD1279bffe-3494-4016-803c-abbf8fd8f0235
835603tramadol hydrochloride 50 MG Oral TabletSCD94a85fdc-6b17-4af8-a0c9-a7cda7c5a6865
835603tramadol hydrochloride 50 MG Oral TabletSCD402ff644-9f7b-46f3-b62c-d0f031575a405
835603traMADol HCl 50 MG Oral TabletPSN3fcc00a9-660f-6568-e054-00144ff88e884
835603traMADol HCl 50 MG Oral TabletPSN648d4e25-d72d-4434-b5fe-119b6c586afe4
835603traMADol HCl 50 MG Oral TabletPSN5babcfcf-331b-5db9-e053-2a91aa0aaf894
835603tramadol hydrochloride 50 MG Oral TabletSCD3fcc00a9-660f-6568-e054-00144ff88e884
835603tramadol hydrochloride 50 MG Oral TabletSCD648d4e25-d72d-4434-b5fe-119b6c586afe4
835603tramadol hydrochloride 50 MG Oral TabletSCD5babcfcf-331b-5db9-e053-2a91aa0aaf894
835603traMADol HCl 50 MG Oral TabletPSN379f8193-c371-4ae9-a272-43c5b9b183493
835603traMADol HCl 50 MG Oral TabletPSNefb84d69-fbc8-43a5-9c27-73fc8b665dd43
835603traMADol HCl 50 MG Oral TabletPSN58c2975a-47bd-4d3c-9cfe-9ea59f3f31ca3
835603traMADol HCl 50 MG Oral TabletPSN4a17d714-9151-4e20-bfab-3deddbf8e04f3
835603tramadol hydrochloride 50 MG Oral TabletSCD379f8193-c371-4ae9-a272-43c5b9b183493
835603tramadol hydrochloride 50 MG Oral TabletSCDefb84d69-fbc8-43a5-9c27-73fc8b665dd43
835603tramadol hydrochloride 50 MG Oral TabletSCD4a17d714-9151-4e20-bfab-3deddbf8e04f3
835603tramadol hydrochloride 50 MG Oral TabletSCD58c2975a-47bd-4d3c-9cfe-9ea59f3f31ca3
835603traMADol HCl 50 MG Oral TabletPSN903993bc-2f60-4a60-a787-03945d1abd462
835603traMADol HCl 50 MG Oral TabletPSN4acbc6df-7616-413c-bcca-2be75a176dcf2
835603traMADol HCl 50 MG Oral TabletPSN3981b2f1-3045-4a37-96e1-059e913e85aa2
835603traMADol HCl 50 MG Oral TabletPSN19f1f780-9b4e-43a6-a758-9d7a3e5e4a602
835603traMADol HCl 50 MG Oral TabletPSNd5ab4f08-1d12-4c64-b3bf-e72c705aeca82
835603traMADol HCl 50 MG Oral TabletPSNac536879-c38b-4012-ae72-655ff98666912
835603tramadol hydrochloride 50 MG Oral TabletSCDac536879-c38b-4012-ae72-655ff98666912
835603tramadol hydrochloride 50 MG Oral TabletSCD19f1f780-9b4e-43a6-a758-9d7a3e5e4a602
835603tramadol hydrochloride 50 MG Oral TabletSCDd5ab4f08-1d12-4c64-b3bf-e72c705aeca82
835603tramadol hydrochloride 50 MG Oral TabletSCD4acbc6df-7616-413c-bcca-2be75a176dcf2
835603tramadol hydrochloride 50 MG Oral TabletSCD3981b2f1-3045-4a37-96e1-059e913e85aa2
835603tramadol hydrochloride 50 MG Oral TabletSCD903993bc-2f60-4a60-a787-03945d1abd462
835603traMADol HCl 50 MG Oral TabletPSN8d40dce1-8394-d4a7-e053-2995a90a480a1
835603traMADol HCl 50 MG Oral TabletPSN340a7760-50b1-4825-9766-eaaad0dd77121
835603traMADol HCl 50 MG Oral TabletPSNba1be142-668f-41de-a545-852e1e8ff8521
835603traMADol HCl 50 MG Oral TabletPSN257512ba-1ede-4332-8d89-2a6dd6b1a3c51
835603traMADol HCl 50 MG Oral TabletPSNac0b0590-e280-4d20-8238-61e7d4b0d2f31
835603tramadol hydrochloride 50 MG Oral TabletSCDac0b0590-e280-4d20-8238-61e7d4b0d2f31
835603tramadol hydrochloride 50 MG Oral TabletSCD340a7760-50b1-4825-9766-eaaad0dd77121
835603tramadol hydrochloride 50 MG Oral TabletSCD257512ba-1ede-4332-8d89-2a6dd6b1a3c51
835603tramadol hydrochloride 50 MG Oral TabletSCDba1be142-668f-41de-a545-852e1e8ff8521
835603tramadol hydrochloride 50 MG Oral TabletSCD8d40dce1-8394-d4a7-e053-2995a90a480a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-627-016516206270110 TABLET, COATED in 1 BOTTLE (65162-627-01) 2010-11-150000-00-00NoNoCurrent
65162-627-1065162062710100 TABLET, COATED in 1 BOTTLE (65162-627-10) 2010-11-150000-00-00NoNoCurrent
65162-627-11651620627111000 TABLET, COATED in 1 BOTTLE (65162-627-11) 2010-11-150000-00-00NoNoCurrent
65162-627-5065162062750500 TABLET, COATED in 1 BOTTLE (65162-627-50) 2010-11-150000-00-00NoNoCurrent