FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
68180-698
11-digit product format
681800698
Labeler code
68180
Product ID
68180-698_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
200 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 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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-698-01TRAMADOL HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE10026
68180-698-02TRAMADOL HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE50026
68180-698-06TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE3026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-698-06EA - Each68180-698297b71f9-c99b-413d-8556-8dfe002cefff12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]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
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-698TRAMADOL 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 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
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN6bb5be12-59ff-40f4-9841-9c7ab93be2ea19
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD6bb5be12-59ff-40f4-9841-9c7ab93be2ea19
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY6bb5be12-59ff-40f4-9841-9c7ab93be2ea19
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNb2f3f007-6dda-4532-9f7f-d93f6e65254c12
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDb2f3f007-6dda-4532-9f7f-d93f6e65254c12
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYb2f3f007-6dda-4532-9f7f-d93f6e65254c12
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNbf51a3af-cbc6-3021-e053-2a95a90a80b77
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN83367367-5654-4078-831a-69ade48bc7957
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDbf51a3af-cbc6-3021-e053-2a95a90a80b77
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD83367367-5654-4078-831a-69ade48bc7957
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYbf51a3af-cbc6-3021-e053-2a95a90a80b77
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY83367367-5654-4078-831a-69ade48bc7957
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNb3c702f7-0a8c-a52b-e053-2995a90a6df34
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDb3c702f7-0a8c-a52b-e053-2995a90a6df34
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYb3c702f7-0a8c-a52b-e053-2995a90a6df34
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN68484531-f908-473f-a422-f37234de96913
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD68484531-f908-473f-a422-f37234de96913
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY68484531-f908-473f-a422-f37234de96913
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNbe15cd5f-055a-471f-8d24-c20d86fdc9832
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN0bff5535-0239-409e-8a2a-99d5ba38cca32
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDbe15cd5f-055a-471f-8d24-c20d86fdc9832
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD0bff5535-0239-409e-8a2a-99d5ba38cca32
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYbe15cd5f-055a-471f-8d24-c20d86fdc9832
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY0bff5535-0239-409e-8a2a-99d5ba38cca32
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN9af10904-99e3-8e81-e053-2a95a90a4be61
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD9af10904-99e3-8e81-e053-2a95a90a4be61
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
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY9af10904-99e3-8e81-e053-2a95a90a4be61
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
68180-698-0168180069801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-698-01) 2014-08-190000-00-00NoNoCurrent
68180-698-0268180069802500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-698-02) 2014-08-190000-00-00NoNoCurrent
68180-698-066818006980630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-698-06) 2014-08-190000-00-00NoNoCurrent