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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-132-00EA - Each21695-13258b748d3-d4ea-4d4e-be9e-bcdc6fba766612012-07-24
21695-132-08EA - Each21695-132e88224dd-dab1-40d3-9a86-b5a54e062fb312012-07-24
21695-132-10EA - Each21695-132caeddaa7-bdb9-4c6d-a1aa-27c848f826e712012-07-24
21695-132-12EA - Each21695-1325211762b-0e1a-4078-bb4f-67a83afa329012012-07-24
21695-132-16EA - Each21695-132510a15aa-7f67-42c4-b5ba-0ce7716ce02d12012-07-24
21695-132-20EA - Each21695-132a3c06b01-79e1-4ab4-85a1-11488934633412012-07-24
21695-132-21EA - Each21695-132c3ea2f76-32a0-4a27-a6b3-fd39e6e7580812012-07-24
21695-132-24EA - Each21695-132f24ae778-2478-41b6-84aa-a610b239d27612012-07-24
21695-132-28EA - Each21695-132b42f9f1d-817b-4ef8-a4ca-35419aa07fd012012-07-24
21695-132-30EA - Each21695-132ea36838f-7365-439e-8df6-ce64a3e639b612012-07-24
21695-132-45EA - Each21695-1321d92fd1b-61b3-4b1c-978c-b9681a6d626512012-07-24
21695-132-50EA - Each21695-132ef1f25d7-9e0f-4b4d-b68d-7e658d86ced112012-07-24
21695-132-60EA - Each21695-1320b3cd222-127c-4b2d-a8d1-0d08e8434ac012012-07-24
21695-132-64EA - Each21695-132898f31b1-77a6-4b7c-9b3d-33b15cb9538d12012-07-24
21695-132-72EA - Each21695-132d59e50a3-f3c3-496b-b258-0d3b59f37c1512012-07-24
21695-132-78EA - Each21695-132b502cf9a-48a7-4494-b8c2-c38e9c24ef6112012-07-24
21695-132-90EA - Each21695-132e7d70e6a-40e1-4817-9feb-a69f90159cfa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1

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