FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
68180-699
11-digit product format
681800699
Labeler code
68180
Product ID
68180-699_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
300 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 HYDROCHLORIDE300 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
68180-699-01TRAMADOL HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE10026
68180-699-06TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE3026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-699-06EA - Each68180-6999cf196f4-042c-4949-a5b2-3df9ad10a18b12014-09-03

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
68180-699TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 2 package rows20240117_46bb9ae6-3ee8-463c-badb-c7a45a89b84b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNacd5d8e0-a4cc-4654-ae04-faff347a60ca104
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDacd5d8e0-a4cc-4654-ae04-faff347a60ca104
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSYacd5d8e0-a4cc-4654-ae04-faff347a60ca104
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
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNb76c1366-f6c0-42ad-bb19-2b72a91490e413
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDb76c1366-f6c0-42ad-bb19-2b72a91490e413
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSYb76c1366-f6c0-42ad-bb19-2b72a91490e413
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSN93e129c8-64c4-1f6d-e053-2a95a90ac1f83
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCD93e129c8-64c4-1f6d-e053-2a95a90ac1f83
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSY93e129c8-64c4-1f6d-e053-2a95a90ac1f83
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSN3c187736-ea96-4e59-9fe6-cb625a619c632
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNf8c5328d-7b47-626e-e053-6294a90a04b32
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSN09a7af47-423a-1e8b-e063-6394a90a99ef2
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCD3c187736-ea96-4e59-9fe6-cb625a619c632
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDf8c5328d-7b47-626e-e053-6294a90a04b32
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCD09a7af47-423a-1e8b-e063-6394a90a99ef2
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSY09a7af47-423a-1e8b-e063-6394a90a99ef2
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSYf8c5328d-7b47-626e-e053-6294a90a04b32
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSY3c187736-ea96-4e59-9fe6-cb625a619c632
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
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNb8cb8f4c-fa6a-b603-e053-2a95a90aa3bb1
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSN1278980b-4068-df57-e063-6394a90a87421
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
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDb8cb8f4c-fa6a-b603-e053-2a95a90aa3bb1
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCD1278980b-4068-df57-e063-6394a90a87421
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYa26ca887-e26c-4c32-8dbd-1fa2eb6db9dc1
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
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSYb8cb8f4c-fa6a-b603-e053-2a95a90aa3bb1
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSY1278980b-4068-df57-e063-6394a90a87421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-699-0168180069901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-699-01) 2014-08-190000-00-00NoNoCurrent
68180-699-066818006990630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-699-06) 2014-08-190000-00-00NoNoCurrent