TRAMADOL HYDROCHLORIDE

Product NDC
50436-0136
11-digit product format
504360136
Labeler code
50436
Product ID
50436-0136_21a0b421-b871-4a05-8460-fca170ac4f79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA091498
Marketing category
ANDA
Marketing start
2015-05-22
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
2020-12-31
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
50436-0136-1TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
50436-0136-2TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED608
50436-0136-3TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED908
50436-0136-4TRAMADOL HYDROCHLORIDE50 in 1 BOTTLETABLET, FILM COATED508
50436-0136-5TRAMADOL HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1208
50436-0136-6TRAMADOL HYDROCHLORIDE180 in 1 BOTTLETABLET, FILM COATED1808
50436-0136-7TRAMADOL HYDROCHLORIDE240 in 1 BOTTLETABLET, FILM COATED2408
50436-0136-8TRAMADOL HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED158

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0136-1EA - Each50436-013601c67464-4550-42fd-87cc-a07a3bf4da0412018-06-11
50436-0136-2EA - Each50436-01362b1ea7de-5bb9-4174-8bce-9a990034681e12018-06-11
50436-0136-3EA - Each50436-0136a3c5640b-6095-435a-92c0-fc3f4f5b74fb12018-06-11
50436-0136-4EA - Each50436-01366d2b02ba-909a-4a8b-b9b5-8535f28935a212018-06-11
50436-0136-5EA - Each50436-0136f7ae7e8d-416a-4b6b-bdc6-460e768792ac12018-06-11
50436-0136-6EA - Each50436-0136e2028fe5-de29-4776-9533-7d2a6f032b4e12018-06-11
50436-0136-7EA - Each50436-0136522ed968-e0d0-48ea-addf-bc63020ea1e912018-06-11
50436-0136-8EA - Each50436-0136379778c3-cb40-46f8-9f54-c00f086a33a712018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0136TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]8Legacy NDC, 8 package rows20180726_8fbcb289-57fd-42ba-a146-25ea55a80a08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN8fbcb289-57fd-42ba-a146-25ea55a80a088
835603tramadol hydrochloride 50 MG Oral TabletSCD8fbcb289-57fd-42ba-a146-25ea55a80a088

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0136-15043601360130 in 1 BOTTLEHistorical
50436-0136-25043601360260 in 1 BOTTLEHistorical
50436-0136-35043601360390 in 1 BOTTLEHistorical
50436-0136-45043601360450 in 1 BOTTLEHistorical
50436-0136-550436013605120 in 1 BOTTLEHistorical
50436-0136-650436013606180 in 1 BOTTLEHistorical
50436-0136-750436013607240 in 1 BOTTLEHistorical
50436-0136-85043601360815 in 1 BOTTLEHistorical