FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
47335-860
11-digit product format
473350860
Labeler code
47335
Product ID
47335-860_a994e116-d201-47f9-baaf-dd76a84eba7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA201384
Marketing category
ANDA
Marketing start
2011-12-12
Substance
TRAMADOL HYDROCHLORIDE
Active strength
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833709, 833711, 833713

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-860-08TRAMADOL HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE10024
47335-860-18TRAMADOL HYDROCHLORIDE1000 in 1 BOTTLETABLET, EXTENDED RELEASE100024
47335-860-83TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE3024
47335-860-88TRAMADOL HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE10024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-860-83EA - Each47335-86083a96084-b74c-4cd9-8be4-815103fafa0112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ATRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ATRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-860TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]21Current NDC, Legacy NDC, 4 package rows20231213_004de5a4-80f8-4040-a6ea-be5e99352a36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN004de5a4-80f8-4040-a6ea-be5e99352a3624
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN004de5a4-80f8-4040-a6ea-be5e99352a3624
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSN004de5a4-80f8-4040-a6ea-be5e99352a3624
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD004de5a4-80f8-4040-a6ea-be5e99352a3624
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD004de5a4-80f8-4040-a6ea-be5e99352a3624
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCD004de5a4-80f8-4040-a6ea-be5e99352a3624
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY004de5a4-80f8-4040-a6ea-be5e99352a3624
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY004de5a4-80f8-4040-a6ea-be5e99352a3624
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSY004de5a4-80f8-4040-a6ea-be5e99352a3624
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
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN66359f41-9999-4cb8-b632-1fe2ec1e60b26
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD66359f41-9999-4cb8-b632-1fe2ec1e60b26
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY66359f41-9999-4cb8-b632-1fe2ec1e60b26
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN7d641da7-1a42-187b-e053-2991aa0afd4b2
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD7d641da7-1a42-187b-e053-2991aa0afd4b2
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY7d641da7-1a42-187b-e053-2991aa0afd4b2
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNdce0d21e-e4c2-4875-a2ce-9d53df190b801
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN00b7f61b-5173-43e6-a3f9-d2efbda40c191
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNf32e70e0-53ae-3ea5-e053-2a95a90aa24e1
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNdce0d21e-e4c2-4875-a2ce-9d53df190b801
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNdce0d21e-e4c2-4875-a2ce-9d53df190b801
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDdce0d21e-e4c2-4875-a2ce-9d53df190b801
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDf32e70e0-53ae-3ea5-e053-2a95a90aa24e1
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDdce0d21e-e4c2-4875-a2ce-9d53df190b801
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD00b7f61b-5173-43e6-a3f9-d2efbda40c191
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDdce0d21e-e4c2-4875-a2ce-9d53df190b801
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYdce0d21e-e4c2-4875-a2ce-9d53df190b801
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYf32e70e0-53ae-3ea5-e053-2a95a90aa24e1
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY00b7f61b-5173-43e6-a3f9-d2efbda40c191
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYdce0d21e-e4c2-4875-a2ce-9d53df190b801
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSYdce0d21e-e4c2-4875-a2ce-9d53df190b801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-860-0847335086008100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-860-08) 2011-12-120000-00-00NoNoCurrent
47335-860-18473350860181000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-860-18) 2011-12-120000-00-00NoNoCurrent
47335-860-834733508608330 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-860-83) 2011-12-120000-00-00NoNoCurrent
47335-860-8847335086088100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-860-88) 2011-12-120000-00-00NoNoCurrent