FDA.reportPublic FDA data

tramadol hydrochloride

Product NDC
57664-377
11-digit product format
576640377
Labeler code
57664
Product ID
57664-377_ec6ca108-bbe1-46af-e053-2995a90a04c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
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
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-377-08EA - Each57664-37742e2d73b-53b7-44a5-9f4e-ddf8afdef3f212012-07-24
57664-377-13EA - Each57664-377709c10be-ee1d-4429-a568-c64651c92fe512012-07-24
57664-377-18EA - Each57664-3770363607a-e255-4c1f-a824-e6ee6951eb4312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]12
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]12
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]12
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]1
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [STAT RX USA 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
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-377TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]28Legacy NDC20250114_cabccc8a-6f9f-414c-93f0-6dec331ed74b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN908cfd1e-d668-59c0-e053-2a95a90a92c29
835603tramadol hydrochloride 50 MG Oral TabletSCD908cfd1e-d668-59c0-e053-2a95a90a92c29
835603traMADol HCl 50 MG Oral TabletPSN71118582-d521-4003-b18b-a7bf82c3d2868
835603tramadol hydrochloride 50 MG Oral TabletSCD71118582-d521-4003-b18b-a7bf82c3d2868
835603traMADol HCl 50 MG Oral TabletPSNf4ae0017-5050-4b92-9944-340385152b957
835603traMADol HCl 50 MG Oral TabletPSNa0ad984a-38da-1fe0-e053-2995a90af23e7
835603tramadol hydrochloride 50 MG Oral TabletSCDa0ad984a-38da-1fe0-e053-2995a90af23e7
835603tramadol hydrochloride 50 MG Oral TabletSCDf4ae0017-5050-4b92-9944-340385152b957
835603traMADol HCl 50 MG Oral TabletPSN4e2c0893-6faf-15ed-e054-00144ff8d46c5
835603tramadol hydrochloride 50 MG Oral TabletSCD4e2c0893-6faf-15ed-e054-00144ff8d46c5
835603traMADol HCl 50 MG Oral TabletPSN9ba9c68c-ff27-eb24-e053-2a95a90ae21c4
835603tramadol hydrochloride 50 MG Oral TabletSCD9ba9c68c-ff27-eb24-e053-2a95a90ae21c4
835603traMADol HCl 50 MG Oral TabletPSN42624fb5-5518-4fae-bf40-5ba69e16240b3
835603tramadol hydrochloride 50 MG Oral TabletSCD42624fb5-5518-4fae-bf40-5ba69e16240b3
835603traMADol HCl 50 MG Oral TabletPSNb3e15b56-45eb-979c-e053-2a95a90a14b11
835603traMADol HCl 50 MG Oral TabletPSN38da58e9-79a6-447d-a07c-0f0084fb03ff1
835603traMADol HCl 50 MG Oral TabletPSNdd5387d7-17c3-4949-978a-3ca5578364c11
835603traMADol HCl 50 MG Oral TabletPSNd5576a76-b16c-4db2-a762-c03194b1e44c1
835603traMADol HCl 50 MG Oral TabletPSNb533007a-ffe8-4de7-e053-2a95a90a19011
835603traMADol HCl 50 MG Oral TabletPSNa9cbcaf6-9312-7f66-e053-2995a90ad12d1
835603traMADol HCl 50 MG Oral TabletPSN592cc647-c395-3e30-e053-2991aa0a506d1
835603tramadol hydrochloride 50 MG Oral TabletSCDb3e15b56-45eb-979c-e053-2a95a90a14b11
835603tramadol hydrochloride 50 MG Oral TabletSCD592cc647-c395-3e30-e053-2991aa0a506d1
835603tramadol hydrochloride 50 MG Oral TabletSCDb533007a-ffe8-4de7-e053-2a95a90a19011
835603tramadol hydrochloride 50 MG Oral TabletSCDd5576a76-b16c-4db2-a762-c03194b1e44c1
835603tramadol hydrochloride 50 MG Oral TabletSCDdd5387d7-17c3-4949-978a-3ca5578364c11
835603tramadol hydrochloride 50 MG Oral TabletSCDa9cbcaf6-9312-7f66-e053-2995a90ad12d1
835603tramadol hydrochloride 50 MG Oral TabletSCD38da58e9-79a6-447d-a07c-0f0084fb03ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-377-0857664037708100 TABLET in 1 BOTTLE (57664-377-08) 100 tablet2002-06-220000-00-00NoNoCurrent
57664-377-1357664037713500 TABLET in 1 BOTTLE (57664-377-13) 500 tablet2002-06-220000-00-00NoNoCurrent
57664-377-18576640377181000 TABLET in 1 BOTTLE (57664-377-18) 1000 tablet2002-06-220000-00-00NoNoCurrent