FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
68180-697
11-digit product format
681800697
Labeler code
68180
Product ID
68180-697_89cbc1ac-6681-42a9-b52a-0094f9b158a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA200503
Marketing category
ANDA
Marketing start
2014-08-19
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 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
68180-697-01TRAMADOL HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE10026
68180-697-02TRAMADOL HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE50026
68180-697-06TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE3026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-697-06EA - Each68180-69776e82c93-94e6-4e3e-bfa9-26d695fcfcab12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]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
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]1
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]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
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]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
68180-697TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 3 package rows20240117_46bb9ae6-3ee8-463c-badb-c7a45a89b84b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN8cc09b31-6067-44ec-8aba-ea7bb1a1f448105
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD8cc09b31-6067-44ec-8aba-ea7bb1a1f448105
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY8cc09b31-6067-44ec-8aba-ea7bb1a1f448105
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN46bb9ae6-3ee8-463c-badb-c7a45a89b84b26
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN46bb9ae6-3ee8-463c-badb-c7a45a89b84b26
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSN46bb9ae6-3ee8-463c-badb-c7a45a89b84b26
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD46bb9ae6-3ee8-463c-badb-c7a45a89b84b26
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD46bb9ae6-3ee8-463c-badb-c7a45a89b84b26
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCD46bb9ae6-3ee8-463c-badb-c7a45a89b84b26
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY46bb9ae6-3ee8-463c-badb-c7a45a89b84b26
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY46bb9ae6-3ee8-463c-badb-c7a45a89b84b26
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSY46bb9ae6-3ee8-463c-badb-c7a45a89b84b26
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN16053b28-c759-4914-93e6-2de0afe7244523
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD16053b28-c759-4914-93e6-2de0afe7244523
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY16053b28-c759-4914-93e6-2de0afe7244523
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
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNc28c98ac-7e07-46a5-8f34-57c008308fba8
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDc28c98ac-7e07-46a5-8f34-57c008308fba8
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYc28c98ac-7e07-46a5-8f34-57c008308fba8
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNb4cd4b64-7db5-da44-e053-2995a90a89537
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDb4cd4b64-7db5-da44-e053-2995a90a89537
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYb4cd4b64-7db5-da44-e053-2995a90a89537
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNc30f6e9e-8014-40fc-9615-a6b8654137c13
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN93c9c960-afbf-6d3d-e053-2995a90a8d153
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDc30f6e9e-8014-40fc-9615-a6b8654137c13
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD93c9c960-afbf-6d3d-e053-2995a90a8d153
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY93c9c960-afbf-6d3d-e053-2995a90a8d153
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYc30f6e9e-8014-40fc-9615-a6b8654137c13
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN7e421fb6-737c-49b3-b299-50511e281a4d2
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNf63facd7-519b-4e2b-b54f-c17fc9ede55f2
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDf63facd7-519b-4e2b-b54f-c17fc9ede55f2
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD7e421fb6-737c-49b3-b299-50511e281a4d2
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYf63facd7-519b-4e2b-b54f-c17fc9ede55f2
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY7e421fb6-737c-49b3-b299-50511e281a4d2
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN9af04fba-ba9d-3691-e053-2995a90a12e21
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN2f23ba6c-89d2-cc42-e063-6394a90aee0a1
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNc2db6902-118d-58c2-e053-2a95a90ac3081
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD2f23ba6c-89d2-cc42-e063-6394a90aee0a1
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD9af04fba-ba9d-3691-e053-2995a90a12e21
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDc2db6902-118d-58c2-e053-2a95a90ac3081
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYc2db6902-118d-58c2-e053-2a95a90ac3081
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY9af04fba-ba9d-3691-e053-2995a90a12e21
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY2f23ba6c-89d2-cc42-e063-6394a90aee0a1
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSYa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-697-0168180069701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-697-01) 2014-08-190000-00-00NoNoCurrent
68180-697-0268180069702500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-697-02) 2014-08-190000-00-00NoNoCurrent
68180-697-066818006970630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-697-06) 2014-08-190000-00-00NoNoCurrent