TRAMADOL HYDROCHLORIDE

Product NDC
76519-1132
11-digit product format
765191132
Labeler code
76519
Product ID
76519-1132_60a69afa-3499-3562-e053-2a91aa0a78d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
H. J. Harkins Company Inc.
Application
ANDA201384
Marketing category
ANDA
Marketing start
2017-01-03
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
200 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
76519-1132-32020-01-31C16284748780-19d75b9d0-6ed4-f424-e053-dadaa90a57ce60a64ffe-c63f-f222-e053-2a91aa0a9db1
76519-1132-62020-01-31C16284748780-19d75b9d0-6ed4-f424-e053-dadaa90a57ce60a64ffe-c63f-f222-e053-2a91aa0a9db1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1132-3TRAMADOL HYDROCHLORIDE30 in 1 CONTAINERTABLET, COATED301
76519-1132-6TRAMADOL HYDROCHLORIDE60 in 1 CONTAINERTABLET, COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1132TRAMADOL HYDROCHLORIDE TABLET, COATED [H. J. HARKINS COMPANY INC.]1Legacy NDC, 2 package rows20171219_60a64ffe-c63f-f222-e053-2a91aa0a9db1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN60a64ffe-c63f-f222-e053-2a91aa0a9db11
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD60a64ffe-c63f-f222-e053-2a91aa0a9db11
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY60a64ffe-c63f-f222-e053-2a91aa0a9db11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76519-1132-37651911320330 in 1 CONTAINERHistorical
76519-1132-67651911320660 in 1 CONTAINERHistorical