tramadol hydrochloride

Product NDC
33261-483
11-digit product format
332610483
Labeler code
33261
Product ID
33261-483_5e9ad922-f27b-413e-9b11-a1a649e4c695
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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]
NDC exclude flag
No
Listing certified through
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-483-02tramadol hydrochloride120 in 1 BOTTLETABLET1201
33261-483-30tramadol hydrochloride30 in 1 BOTTLETABLET301
33261-483-60tramadol hydrochloride60 in 1 BOTTLETABLET601
33261-483-90tramadol hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-483-02EA - Each33261-483ee506f3f-c973-4b8c-834d-85af11ba41a912015-10-02
33261-483-30EA - Each33261-4835ce9874b-af22-4db7-b987-2a32f390bc4112015-10-02
33261-483-60EA - Each33261-483cf857c99-cd2a-4b44-9ed1-bff3084e03eb12015-10-02
33261-483-90EA - Each33261-48317561a58-e98a-46d1-9023-e97469ab869112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS 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
33261-483TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20121007_38da58e9-79a6-447d-a07c-0f0084fb03ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN38da58e9-79a6-447d-a07c-0f0084fb03ff1
835603tramadol hydrochloride 50 MG Oral TabletSCD38da58e9-79a6-447d-a07c-0f0084fb03ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-483-0233261048302120 in 1 BOTTLEHistorical
33261-483-303326104833030 in 1 BOTTLEHistorical
33261-483-603326104836060 in 1 BOTTLEHistorical
33261-483-903326104839090 in 1 BOTTLEHistorical