FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
21695-132
11-digit product format
216950132
Labeler code
21695
Product ID
21695-132_ba1be142-668f-41de-a545-852e1e8ff852
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA076003
Marketing category
ANDA
Marketing start
2009-11-23
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
E
Listing certified through
2017-12-31
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
21695-132-002019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-082019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-102019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-122019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-162019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-202019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-212019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-242019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-282019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-302019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-452019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-502019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-602019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-642019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-722019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-782019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets
21695-132-902019-09-24C16284748780-1934fe258-4785-48b1-e053-8cdaa90a720aTramadol Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-132-00Tramadol Hydrochloride100 in 1 BOTTLETABLET1001
21695-132-08Tramadol Hydrochloride8 in 1 BOTTLETABLET81
21695-132-10Tramadol Hydrochloride10 in 1 BOTTLETABLET101
21695-132-12Tramadol Hydrochloride12 in 1 BOTTLETABLET121
21695-132-16Tramadol Hydrochloride16 in 1 BOTTLETABLET161
21695-132-20Tramadol Hydrochloride20 in 1 BOTTLETABLET201
21695-132-21Tramadol Hydrochloride21 in 1 BOTTLETABLET211
21695-132-24Tramadol Hydrochloride24 in 1 BOTTLETABLET241
21695-132-28Tramadol Hydrochloride28 in 1 BOTTLETABLET281
21695-132-30Tramadol Hydrochloride30 in 1 BOTTLETABLET301
21695-132-45Tramadol Hydrochloride45 in 1 BOTTLETABLET451
21695-132-50Tramadol Hydrochloride50 in 1 BOTTLETABLET501
21695-132-60Tramadol Hydrochloride60 in 1 BOTTLETABLET601
21695-132-64Tramadol Hydrochloride240 in 1 BOTTLETABLET2401
21695-132-72Tramadol Hydrochloride120 in 1 BOTTLETABLET1201
21695-132-78Tramadol Hydrochloride180 in 1 BOTTLETABLET1801
21695-132-90Tramadol Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-132TRAMADOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 17 package rows20110512_ba1be142-668f-41de-a545-852e1e8ff852.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNba1be142-668f-41de-a545-852e1e8ff8521
835603tramadol hydrochloride 50 MG Oral TabletSCDba1be142-668f-41de-a545-852e1e8ff8521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-132-0021695013200100 in 1 BOTTLEHistorical
21695-132-08216950132088 in 1 BOTTLEHistorical
21695-132-102169501321010 in 1 BOTTLEHistorical
21695-132-122169501321212 in 1 BOTTLEHistorical
21695-132-162169501321616 in 1 BOTTLEHistorical
21695-132-202169501322020 in 1 BOTTLEHistorical
21695-132-212169501322121 in 1 BOTTLEHistorical
21695-132-242169501322424 in 1 BOTTLEHistorical
21695-132-282169501322828 in 1 BOTTLEHistorical
21695-132-302169501323030 in 1 BOTTLEHistorical
21695-132-452169501324545 in 1 BOTTLEHistorical
21695-132-502169501325050 in 1 BOTTLEHistorical
21695-132-602169501326060 in 1 BOTTLEHistorical
21695-132-6421695013264240 in 1 BOTTLEHistorical
21695-132-7221695013272120 in 1 BOTTLEHistorical
21695-132-7821695013278180 in 1 BOTTLEHistorical
21695-132-902169501329090 in 1 BOTTLEHistorical