FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
33261-105
11-digit product format
332610105
Labeler code
33261
Product ID
33261-105_1dcbca44-a8e9-47a2-8c61-2758dd586a83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076003
Marketing category
ANDA
Marketing start
2010-11-15
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-105-002020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-022020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-042020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-092020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-102020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-152020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-162020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-202020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-302020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-402020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-452020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-502020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-602020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-902020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-912020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-982020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP
33261-105-992020-01-31C16284748780-19d75b9d0-6595-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-105-00Tramadol Hydrochloride100 in 1 BOTTLETABLET, COATED1002
33261-105-02Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED1202
33261-105-04Tramadol Hydrochloride240 in 1 BOTTLETABLET, COATED2402
33261-105-09Tramadol Hydrochloride9 in 1 BOTTLETABLET, COATED92
33261-105-10Tramadol Hydrochloride10 in 1 BOTTLETABLET, COATED102
33261-105-15Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED152
33261-105-16Tramadol Hydrochloride16 in 1 BOTTLETABLET, COATED162
33261-105-20Tramadol Hydrochloride20 in 1 BOTTLETABLET, COATED202
33261-105-30Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED302
33261-105-40Tramadol Hydrochloride40 in 1 BOTTLETABLET, COATED402
33261-105-45Tramadol Hydrochloride45 in 1 BOTTLETABLET, COATED452
33261-105-50Tramadol Hydrochloride50 in 1 BOTTLETABLET, COATED502
33261-105-60Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED602
33261-105-90Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED902
33261-105-91Tramadol Hydrochloride200 in 1 BOTTLETABLET, COATED2002
33261-105-98Tramadol Hydrochloride168 in 1 BOTTLETABLET, COATED1682
33261-105-99Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-105-00EA - Each33261-105d82e7241-b785-42b2-8c70-6b36610bd68f12016-04-04
33261-105-02EA - Each33261-10503f6cb14-196e-451c-af95-3b7c3dd7f61e12016-04-04
33261-105-04EA - Each33261-1050581cfb6-fd58-43ed-ae2e-fe448da3016012016-04-04
33261-105-10EA - Each33261-1055b4c965e-2ded-40ff-907a-b119e0c40fc212016-04-04
33261-105-15EA - Each33261-105b8d39bc8-4866-4291-8ab2-e2827a568f2912016-04-04
33261-105-16EA - Each33261-1057308e525-2551-4599-93a1-dd3356b0dacd12016-04-04
33261-105-20EA - Each33261-105e0b3ac25-aa7b-4440-9eeb-379812f32a8412016-04-04
33261-105-30EA - Each33261-105aadd3976-260b-40a7-a455-6a7429e5c14d12016-04-04
33261-105-45EA - Each33261-105e8cdd03e-a836-40fb-9587-cd0eb7c37c1712016-04-04
33261-105-50EA - Each33261-10541d63f72-bff1-487a-9527-1b512eb9fd6a12016-04-04
33261-105-60EA - Each33261-1051f15f769-4308-41fa-9ffa-582c44a1e4d612016-04-04
33261-105-90EA - Each33261-105a641a7d3-0c51-47b5-b445-d8e1e69bd80312016-04-04
33261-105-91EA - Each33261-105405c76fa-6e9a-456f-adc3-868ea1c3803a12016-04-04
33261-105-98EA - Each33261-105483bd221-f34f-42c4-ba0c-4dbd6e6a518812016-04-04
33261-105-99EA - Each33261-1058ef4ebc9-e807-4148-a7d2-f7a870f84cee12016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-105TRAMADOL HYDROCHLORIDE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 17 package rows20141024_ac536879-c38b-4012-ae72-655ff9866691.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNac536879-c38b-4012-ae72-655ff98666912
835603tramadol hydrochloride 50 MG Oral TabletSCDac536879-c38b-4012-ae72-655ff98666912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-105-0033261010500100 in 1 BOTTLEHistorical
33261-105-0233261010502120 in 1 BOTTLEHistorical
33261-105-0433261010504240 in 1 BOTTLEHistorical
33261-105-09332610105099 in 1 BOTTLEHistorical
33261-105-103326101051010 in 1 BOTTLEHistorical
33261-105-153326101051515 in 1 BOTTLEHistorical
33261-105-163326101051616 in 1 BOTTLEHistorical
33261-105-203326101052020 in 1 BOTTLEHistorical
33261-105-303326101053030 in 1 BOTTLEHistorical
33261-105-403326101054040 in 1 BOTTLEHistorical
33261-105-453326101054545 in 1 BOTTLEHistorical
33261-105-503326101055050 in 1 BOTTLEHistorical
33261-105-603326101056060 in 1 BOTTLEHistorical
33261-105-903326101059090 in 1 BOTTLEHistorical
33261-105-9133261010591200 in 1 BOTTLEHistorical
33261-105-9833261010598168 in 1 BOTTLEHistorical
33261-105-9933261010599180 in 1 BOTTLEHistorical